Apparatus and methods for determining a medical appliance wear time based on sensor data

ABSTRACT

Embodiments for determining an ostomy appliance wear time based on sensor data are disclosed. In an embodiment, an accessory device for an ostomy system comprises a monitor device and an ostomy appliance. The ostomy appliance comprises a base plate. The accessory device comprises: a memory, a processor, and a monitor interface coupled to the processor and configured to communicate with the monitor device and obtain monitor data from the monitor device coupled to the ostomy appliance. The processor is configured to determine an operating state of the base plate, determine sensor data associated with the user, the user&#39;s activities, and/or the user&#39;s environment, and determine an actual wear time of the ostomy appliance based on the operating state and the sensor data.

The present disclosure relates to an accessory device for an ostomy system, devices thereof, and related methods. The ostomy system comprises an ostomy appliance and a monitor device. More specifically, the present disclosure relates to determining ostomy appliance wear time based on sensor data.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings are included to provide a further understanding of embodiments and are incorporated into and a part of this specification. The drawings illustrate embodiments and together with the description serve to explain principles of embodiments. Other embodiments and many of the intended advantages of embodiments will be readily appreciated as they become better understood by reference to the following detailed description. The elements of the drawings are not necessarily to scale relative to each other. Like reference numerals designate corresponding similar parts.

FIG. 1 illustrates an exemplary ostomy system,

FIG. 2 illustrates an exemplary monitor device of the ostomy system,

FIG. 3 is an exploded view of a base plate of an ostomy appliance,

FIG. 4 is an exploded view of an exemplary electrode assembly,

FIG. 5 is a proximal view of parts of a base plate,

FIG. 6 is a distal view of an exemplary electrode configuration,

FIG. 7 is a distal view of an exemplary masking element,

FIG. 8 is a distal view of an exemplary first adhesive layer,

FIG. 9 is a proximal view of the first adhesive layer of FIG. 8,

FIG. 10 is a distal view of a part of the base plate including monitor interface,

FIG. 11 illustrates an exemplary accessory device in connection with the ostomy appliance for performing various functions,

FIG. 12 is an embodiment of a portion of a wear time lookup table for use with an accessory device,

FIG. 13 is an embodiment of a portion of a previous wear time lookup table for use with an accessory device,

FIG. 14 is a graph depicting a previous wear time and actual wear times,

FIG. 15 is an exemplary screen of the accessory device of FIG. 11 depicting activity data,

FIG. 16 is a graph of a plurality of previous sensor parameter values and corresponding previous wear times,

FIG. 17 depicts an embodiment for determining an equation for actual wear time based on previous wear times, and

FIG. 18 is a flow diagram of a method for determining an ostomy appliance wear time based on sensor data.

FIG. 19 is an exemplary graphical representation of parameter data as a function of time,

FIG. 20 is an exemplary graphical representation of parameter data as a function of time,

FIG. 21 is an exemplary graphical representation of parameter data as a function of time,

FIG. 22 is an exemplary graphical representation of parameter data as a function of time and a whitening zone diameter as a function of time,

FIGS. 23A-23B are exemplary graphical representations of peel force as a function of a peeling distance traveled by a peeling action exercising the peel force on a first adhesive layer of a base plate.

FIGS. 24A-24B are exemplary graphical representations of a whitening zone diameter,

FIG. 25A is an exemplary graphical representation of first parameter data as a function of time for various semi-solid matter scenarios,

FIG. 25B is an exemplary graphical representation of first parameter data as a function of percentage of semi-solid matter in the mixture applied to the stomal opening,

FIGS. 26A-26B are exemplary graphical representations of parameter data as functions of time for different predetermined temperatures.

DETAILED DESCRIPTION

Various exemplary embodiments and details are described hereinafter, with reference to the figures when relevant. It should be noted that the figures may or may not be drawn to scale and that elements of similar structures or functions are represented by like reference numerals throughout the figures. It should also be noted that the figures are only intended to facilitate the description of the embodiments. They are not intended as an exhaustive description of the invention or as a limitation on the scope of the invention. In addition, an illustrated embodiment needs not have all the aspects or advantages shown. An aspect or an advantage described in conjunction with a particular embodiment is not necessarily limited to that embodiment and can be practiced in any other embodiments even if not so illustrated, or if not so explicitly described.

Throughout this disclosure, the words “stoma” and “ostomy” are used to denote a surgically created opening bypassing the intestines or urinary tract system of a person. The words are used interchangeably, and no differentiated meaning is intended. The same applies for any words or phrases derived from these, e.g. “stomal”, “ostomies” etc. Also, the solid and liquid wastes emanating from the stoma may be referred to as both stomal “output,” “waste(s),” and “fluids” interchangeably. A subject having undergone ostomy surgery may be referred to as “ostomist” or “ostomate”—moreover, also as “patient” or “user”. However, in some cases “user” may also relate or refer to a health care professional (HCP), such as a surgeon or an ostomy care nurse or others. In those cases, it will either be explicitly stated, or be implicit from the context that the “user” is not the “patient” him- or herself.

In the following, whenever referring to proximal side or surface of a layer, an element, a device or part of a device, the referral is to the skin-facing side or surface, when a user wears the ostomy appliance/monitor device. Likewise, whenever referring to the distal side or surface of a layer, an element, a device or part of a device, the referral is to the side or surface facing away from the skin, when a user wears the ostomy appliance/monitor device. In other words, the proximal side or surface is the side or surface closest to the user, when the appliance is fitted on a user and the distal side is the opposite side or surface—the side or surface furthest away from the user in use.

The axial direction is defined as the direction of the stoma, when a user wears the appliance. Thus, the axial direction is generally perpendicular to the skin or abdominal surface of the user.

The radial direction is defined as perpendicular to the axial direction. In some sentences, the words “inner” and “outer” may be used. These qualifiers should generally be perceived with respect to the radial direction, such that a reference to an “outer” element means that the element is farther away from a centre portion of the ostomy appliance than an element referenced as “inner”. In addition, “innermost” should be interpreted as the portion of a component forming a centre of the component and/or being adjacent to the centre of the component. In analogy, “outermost” should be interpreted as a portion of a component forming an outer edge or outer contour of a component and/or being adjacent to that outer edge or outer contour.

The use of the word “substantially” as a qualifier to certain features or effects in this disclosure is intended to simply mean that any deviations are within tolerances that would normally be expected by the skilled person in the relevant field.

The use of the word “generally” as a qualifier to certain features or effects in this disclosure is intended to simply mean—for a structural feature: that a majority or major portion of such feature exhibits the characteristic in question, and—for a functional feature or an effect: that a majority of outcomes involving the characteristic provide the effect, but that exceptionally outcomes do no provide the effect.

The present disclosure relates to an ostomy system and devices thereof, such as an ostomy appliance, a base plate for an ostomy appliance, a monitor device, and optionally one or more accessory devices. Further, methods related to the ostomy system and devices thereof are disclosed. An accessory device (also referred to as an external device) may be a mobile phone or other handheld device. An accessory device may be a personal electronic device, e.g. a wearable, such as a watch or other wrist-worn electronic device. An accessory device may be a docking station. The docking station may be configured to electrically and/or mechanically couple the monitor device to the docking station. The docking station may be configured for charging the monitor device and/or configured for transferring data between the monitor device and the docking station. The ostomy system may comprise a server device. The server device may be operated and/or controlled by the ostomy appliance manufacturer and/or a service centre.

An ostomy system comprising an ostomy appliance and a monitor device, the ostomy appliance comprising a base plate is disclosed, wherein the monitor device is a monitor device as described herein.

An ostomy system comprising a monitor device and an ostomy appliance comprising a base plate is disclosed, the base plate having a first adhesive layer with a proximal side configured for attachment of the base plate to the skin surface of a user, the first adhesive layer having a stomal opening with a center point, the monitor device comprising a processor and a sensor unit comprising a first sensor with a first sensor surface accommodated in a monitor device housing, the monitor device housing having a sensor opening in a proximal surface of the monitor device, the sensor opening forming at least a part of a sensor path from surroundings of the proximal surface to the first sensor surface.

Also disclosed is a monitor device for an ostomy appliance of an ostomy system, the monitor device comprising a processor and a sensor unit comprising a first sensor with a first sensor surface accommodated in a monitor device housing, the monitor device housing having a sensor opening in a proximal surface of the monitor device, the proximal surface configured for facing the skin of a user during use, the sensor opening forming at least a part of a sensor path from surroundings of the proximal surface to the first sensor surface.

The present disclosure provides an ostomy system and devices thereof, such as an ostomy appliance, a base plate for an ostomy appliance, a monitor device, and optionally one or more accessory devices which either alone or together facilitate reliable determination of the nature, severity and rapidness of moisture propagation in the adhesive material provided for attaching the base plate to the skin surface of a user. Depending on the nature of the pattern of moisture propagation in the adhesive, the ostomy system and devices thereof enable providing information to the user about the type of failure, and in turn enable providing an indication to the user of the severity and thus the remaining time frame for replacing the ostomy appliance without experiencing severe leakage and/or skin damage.

The ostomy appliance comprises a base plate and an ostomy pouch (also referred to as an ostomy bag). The ostomy appliance may be a colostomy appliance, an ileostomy appliance or a urostomy appliance. The ostomy appliance may be a two-part ostomy appliance, i.e. the base plate and the ostomy pouch may be releasably coupled e.g. with a mechanical and/or an adhesive coupling, e.g. to allow that a plurality of ostomy pouches can be utilized (exchanged) with one base plate. Further, a two-part ostomy appliance may facilitate correct application of the base plate to skin, e.g. due to an improved user sight of the stomal region. The ostomy appliance may be a one-part ostomy appliance, i.e. the base plate and the ostomy pouch may be fixedly attached to each other. The base plate is configured for coupling to a user's stoma and/or skin surrounding the stoma, such as a peristomal skin area.

A base plate for an ostomy appliance is disclosed, the base plate comprising a first adhesive layer with a proximal side configured for attachment of the base plate to the skin surface of a user, the first adhesive layer having a stomal opening with a center point; and a plurality of electrodes including a ground electrode, a first electrode, and a optionally a second electrode, the ground electrode comprising a ground connection part, the first electrode comprising a first connection part, and the second electrode comprising a second connection part, wherein the ground electrode forms a ground for the first electrode and/or the second electrode.

The base plate comprises a first adhesive layer. During use, the first adhesive layer adheres to the user's skin (peristomal area) and/or to additional seals, such as sealing paste, sealing tape and/or sealing ring. Thus, the first adhesive layer may be configured for attachment of the base plate to the skin surface of a user. The first adhesive layer has a stomal opening with a center point or is at least prepared for forming a stomal opening with a center point. A base plate with three electrodes having sensing parts with contact to the first adhesive layer allows for determining erosion/swelling properties or characteristics of the first adhesive layer and/or determining a degree of erosion and/or swelling of the first adhesive layer.

It is an advantage of the present disclosure that an optimum or improved use of an ostomy appliance is provided. In particular, the present disclosure facilitates that a base plate is not changed too early (leading to increased cell-stripping from the skin and increased risk of skin damage and further leading to increased costs and/or material waste) nor too late (leading to adhesive failure, leakage and/or skin damage from the aggressive output). Accordingly, the user or a health care professional is able to monitor and plan the use of the ostomy appliance.

Further, determination of operating state and classification of operating states of the ostomy appliance is useful in helping to reduce the risk of a user experiencing leakage from an ostomy appliance. Further, determination of operating state and classification of operating states of the ostomy appliance is further useful in helping reduce the risk of skin damage to a user. In particular, determination of operating state according to the present disclosure may help provide a clear distinction or differentiation between adhesive failure, leakage of output, which is harmful to the skin, and a sweating ostomate.

The present disclosure provides a simple, efficient, and easy-to-use ostomy appliance system with a high degree of comfort for a user.

The first adhesive layer may be made of a first composition. The first composition may comprise one or more polyisobutenes and/or styrene-isoprene-styrene. The first composition may comprise one or more hydrocolloids.

The first composition may be a pressure sensitive adhesive composition suitable for medical purposes comprising a rubbery elastomeric base and one or more water soluble or water swellable hydrocolloids. The first composition may comprise one or more polybutenes, one or more styrene copolymers, one or more hydrocolloids, or any combination thereof. The combination of the adhesive properties of the polybutenes and the absorbing properties of the hydrocolloids renders the first composition suitable for use in ostomy appliances. The styrene copolymer may for example be a styrene-butadiene-styrene block copolymer or a styrene-isoprene-styrene block copolymer. Preferably, one or more styrene-isoprene-styrene (SIS) block type copolymers are employed. The amount of styrene block-copolymer may be from 5% to 20% of the total adhesive composition. The butene component is suitably a conjugated butadiene polymer selected from polybutadiene, polyisoprene. The polybutenes are preferably present in an amount of from 35-50% of the total adhesive composition. Preferably, the polybutene is polyisobutylene (PIB). Suitable hydrocolloids for incorporation in the first composition are selected from naturally occurring hydrocolloids, semisynthetic hydrocolloids and synthetic hydrocolloids. The first composition may comprise 20-60% hydrocolloids. A preferred hydrocolloid is carboxymethyl cellulose (CMC). The first composition may optionally contain other components, such as fillers, tackifiers, plasticizers, and other additives.

The first adhesive layer may have a plurality of sensor point openings. A sensor point opening of the first adhesive layer is optionally configured to overlap a (sensing) part of an electrode, e.g. to form a sensor point.

The sensor point openings of the first adhesive layer may comprise primary sensor point openings. The primary sensor point openings may comprise one or more primary first sensor point openings and one or more primary second sensor point openings, the primary first sensor point openings configured to overlap (sensing) parts of an electrode and the primary second sensor point openings configured to overlap (sensing) parts of another electrode different from the electrode at least partly overlapped by the primary first sensor point openings.

The sensor point openings of the first adhesive layer may comprise secondary sensor point openings. The secondary sensor point openings may comprise one or more secondary first sensor point openings and one or more secondary second sensor point openings, the secondary first sensor point openings configured to overlap (sensing) parts of an electrode and the secondary second sensor point openings configured to overlap (sensing) parts of another electrode different from the electrode at least partly overlapped by the secondary first sensor point openings.

The sensor point openings of the first adhesive layer may comprise tertiary sensor point openings. The tertiary sensor point openings may comprise one or more tertiary first sensor point openings and one or more tertiary second sensor point openings, the tertiary first sensor point openings configured to overlap (sensing) parts of an electrode and the tertiary second sensor point openings configured to overlap (sensing) parts of another electrode different from the electrode at least partly overlapped by the tertiary first sensor point openings.

The first adhesive layer may have a substantially uniform thickness. The first adhesive layer may have a thickness in the range from 0.1 mm to 1.5 mm, e.g. in the range from 0.2 mm to 1.2 mm, such as 0.8 mm or 1.0 mm.

The first adhesive layer may have a primary thickness in a primary part of the first adhesive layer, e.g. in a primary region within a primary radial distance or in a primary radial distance range from the center point of the stomal opening. The primary thickness may be in the range from 0.2 mm to 1.5 mm. such as about 1.0 mm. The primary radial distance may be in the range from 20 mm to 50 mm, such as in the range from 25 mm to 35 mm, e.g. 30 mm.

The first adhesive layer may have a secondary thickness in a secondary part of the first adhesive layer, e.g. in a secondary region outside a secondary radial distance or in a secondary radial distance range from the center point of the stomal opening. The secondary thickness may be in the range from 0.2 mm to 1.0 mm, such as about 0.5 mm. The secondary radial distance may be in the range from 20 mm to 50 mm, such as in the range from 25 mm to 35 mm, e.g. 30 mm.

The base plate may comprise a second layer. The second layer may be a second adhesive layer, also denoted rim adhesive layer. The second layer may have a second radial extension that is larger than a first radial extension of the first adhesive layer at least in a first angular range of the base plate. Accordingly, a part of a proximal surface of the second layer may be configured for attachment to the skin surface of a user. The part of a proximal surface of the second layer configured for attachment to the skin surface of a user is also denoted the skin attachment surface of the second adhesive layer. The second layer may have a stomal opening with a center point.

The second adhesive layer may be made of a second composition. The second composition may comprise one or more polyisobutenes and/or styrene-isoprene-styrene. The second composition may comprise one or more hydrocolloids.

The second composition may be a pressure sensitive adhesive composition suitable for medical purposes comprising a rubbery elastomeric base and one or more water soluble or water swellable hydrocolloids. The second composition may comprise one or more polybutenes, one or more styrene copolymers, one or more hydrocolloids, or any combination thereof. The combination of the adhesive properties of the polybutenes and the absorbing properties of the hydrocolloids renders the second composition suitable for use in ostomy appliances. The styrene copolymer may for example be a styrene-butadiene-styrene block copolymer or a styrene-isoprene-styrene block copolymer. Preferably, one or more styrene-isoprene-styrene (SIS) block type copolymers are employed. The amount of styrene block-copolymer may be from 5% to 20% of the total adhesive composition. The butene component is suitably a conjugated butadiene polymer selected from polybutadiene, polyisoprene. The polybutenes are preferably present in an amount of from 35-50% of the total adhesive composition. Preferably, the polybutene is polyisobutylene (PIB). Suitable hydrocolloids for incorporation in the second composition are selected from naturally occurring hydrocolloids, semisynthetic hydrocolloids and synthetic hydrocolloids. The second composition may comprise 20-60% hydrocolloids. A preferred hydrocolloid is carboxymethyl cellulose (CMC). The second composition may optionally contain other components, such as fillers, tackifiers, plasticizers, and other additives.

Different ratio of contents may change properties of the first and/or second adhesive layers. The second adhesive layer and the first adhesive layer may have different properties. The second adhesive layer (second composition) and the first adhesive layer (first composition) may have different ratios of polyisobutenes, styrene-isoprene-styrene, and/or hydrocolloids. For example, the second adhesive layer may provide a stronger attachment to the skin compared to attachment to the skin provided by the first adhesive layer. Alternatively or additionally, the second adhesive layer may be thinner than the first adhesive layer. Alternatively or additionally, the second adhesive layer may be less water and/or sweat absorbing than the first adhesive layer. Alternatively or additionally, the second adhesive layer may be less moldable than the first adhesive layer. The second adhesive layer may provide a second barrier against leakage.

The second layer may have a substantially uniform thickness. The second layer may have a thickness in the range from 0.1 mm to 1.5 mm, e.g. in the range from 0.2 mm to 1.0 mm, such as 0.5 mm, 0.6 mm, or 0.7 mm.

The base plate comprises one or more electrodes, such as a plurality of electrodes, such as two, three, four, five, six, seven or more electrodes. The electrodes, e.g. some or all the electrodes, may be arranged between the first adhesive layer and the second adhesive layer. The electrodes may be arranged in an electrode assembly, e.g. an electrode layer. An electrode comprises a connection part for connecting the electrodes to other components and/or interface terminals/terminal elements. An electrode may comprise one or more conductor parts and/or one or more sensing parts. The electrode assembly may be arranged between the first adhesive layer and the second adhesive layer. The base plate, e.g. the electrode assembly, may comprise a first electrode, a second electrode and optionally a third electrode. The base plate, e.g. the electrode assembly, may comprise a fourth electrode and/or a fifth electrode. The base plate, e.g. the electrode assembly, optionally comprises a sixth electrode. The base plate, e.g. the electrode assembly, may comprise a ground electrode. The ground electrode may comprise a first electrode part. The first electrode part of the ground electrode may form a ground or reference for the first electrode. The ground electrode may comprise a second electrode part. The second electrode part of the ground electrode may form a ground or reference for the second electrode. The ground electrode may comprise a third electrode part. The third electrode part of the ground electrode may form a ground or reference for the third electrode. The ground electrode may comprise a fourth electrode part. The fourth electrode part of the ground electrode may form a ground or reference for the fourth electrode and/or the fifth electrode.

The ground electrode or electrode parts of the ground electrode may be configured as or form a (common) reference electrode for some or all of the other electrodes of the electrode assembly. The ground electrode may also be denoted reference electrode.

The electrodes are electrically conductive and may comprise one or more of metallic (e.g. silver, copper, gold, titanium, aluminium, stainless steel), ceramic (e.g. ITO), polymeric (e.g. PEDOT, PANI, PPy), and carbonaceous (e.g. carbon black, carbon nanotube, carbon fibre, graphene, graphite) materials.

The ground electrode may comprise a first electrode part and a second electrode part, the first electrode part forming the ground for the first electrode and the second electrode part forming the ground for the second electrode. The first electrode part may form a closed loop.

The electrodes are electrically conductive and may comprise one or more of metallic (e.g. silver, copper, gold, titanium, aluminium, stainless steel), ceramic (e.g. ITO), polymeric (e.g. PEDOT, PANI, PPy), and carbonaceous (e.g. carbon black, carbon nanotube, carbon fibre, graphene, graphite) materials.

Two electrodes of the electrode assembly may form a sensor. The first electrode and the ground electrode (e.g. first electrode part of the ground electrode) may form a first sensor or first electrode pair. The second electrode and the ground electrode (e.g. second electrode part of the ground electrode) may form a second sensor or second electrode pair. The third electrode and the ground electrode (e.g. third electrode part of the ground electrode) may form a third sensor or third electrode pair. The fourth electrode and the ground electrode (e.g. fourth electrode part of the ground electrode) may form a fourth sensor or fourth electrode pair. The fifth electrode and the ground electrode (e.g. fifth electrode part of the ground electrode) may form a fifth sensor or fifth electrode pair. The fourth electrode and the fifth electrode may form a sixth sensor or sixth electrode pair.

An electrode may comprise a sensing part or a plurality of sensing parts, i.e. the part(s) of an electrode that are used for sensing. The first electrode may comprise a first sensing part. The first sensing part may contact the first adhesive layer and is optionally arranged at least partly annularly around the stomal opening. The first electrode may comprise a first conductor part insulated from the first adhesive layer, e.g. by a masking element arranged between the first conductor part and the first adhesive layer. The first sensing part may extend at least 270 degrees around the stomal opening, such as at least 300 degrees around the stomal opening. The first sensing part of the first electrode may be arranged at a first ground distance from the first electrode part of the ground electrode. The first ground distance may be less than 5 mm, such as less than 3 mm, e.g. about 1.0 mm.

The second electrode may comprise a second sensing part. The second sensing part may contact the first adhesive layer. The second sensing part may be arranged at least partly annularly around the stomal opening. The second sensing part may extend at least 270 degrees around the stomal opening, such as at least 300 degrees around the stomal opening. The second sensing part of the second electrode may be arranged at a second ground distance from the second electrode part of the ground electrode. The second ground distance may be less than 5 mm, such as less than 3 mm, e.g. about 1.0 mm.

The first sensing part may be arranged at a first radial distance from the center point and the second sensing part may be arranged at a second radial distance from the center point. The second radial distance may be larger than the first radial distance. The second electrode may comprise a second conductor part insulated from the first adhesive layer, e.g. by a masking element arranged between the second conductor part and the first adhesive layer. The first radial distance may vary as a function of an angular position with respect to a zero direction from the center point. The second radial distance may vary as a function of an angular position with respect to a zero direction from the center point. The zero direction may be defined as the vertical upward direction when the base plate is in its intended wearing position on an upstanding user.

The first radial distance may be in the range from 5 mm to 40 mm, such as in the range from 10 mm to 25 mm, e.g. about 14 mm. The second radial distance may be in the range from 10 mm to 50 mm, such as in the range from 10 mm to 25 mm, e.g. about 18 mm.

The base plate may comprise a third electrode comprising a third connection part. The ground electrode may form a ground for the third electrode. The ground electrode may comprise a third electrode part, the third electrode part forming the ground for the third electrode. The third electrode may comprise a third conductor part insulated from the first adhesive layer, e.g. by a masking element arranged between the third conductor part and the first adhesive layer. The third electrode may comprise a third sensing part, the third sensing part contacting the first adhesive layer. The third sensing part may be arranged at least partly annularly around the stomal opening. The third sensing part may be arranged at a third radial distance from the center point. The third radial distance may be larger than the first radial distance and/or larger than the second radial distance. The third radial distance may be in the range from 15 mm to 50 mm. such as in the range from 20 mm to 30 mm, e.g. about 26 mm. The third sensing part may extend at least 270 degrees around the stomal opening, such as at least 300 degrees around the stomal opening. The third sensing part of the third electrode may be arranged at a third ground distance from the third electrode part of the ground electrode. The third ground distance may be less than 5 mm, such as less than 3 mm, e.g. about 1.0 mm. A base plate with a ground electrode, a first electrode, a second electrode, and a third electrode allow for a failsafe base plate in case e.g. the first electrode is cut or otherwise destroyed during preparation of the base plate.

The base plate may comprise a fourth electrode comprising a fourth connection part. The ground electrode may form a ground for the fourth electrode. The ground electrode may comprise a fourth electrode part, the fourth electrode part forming the ground for the fourth electrode. The fourth electrode may comprise one or a plurality of fourth sensing parts, such as at least five fourth sensing parts. The fourth sensing parts may be distributed around the stomal opening or a center point thereof. The fourth sensing parts may be arranged at respective fourth radial distances from the center point. The fourth radial distance(s) may be larger than the third radial distance. The fourth radial distance(s) may be in the range from 25 mm to 50 mm, such as about 30 mm.

The base plate may comprise a fifth electrode comprising a fifth connection part. The ground electrode may form a ground for the fifth electrode. The ground electrode may comprise a fifth electrode part, the fifth electrode part forming the ground for the fifth electrode. The fifth electrode may comprise one or a plurality of fifth sensing parts, such as at least five fifth sensing parts. The fifth sensing parts may be distributed around the stomal opening or a center point thereof. The fifth sensing parts may be arranged at respective fifth radial distances from the center point. The fifth radial distance may be larger than the third radial distance. The fifth radial distance may be equal to or larger than the fourth radial distance. The fifth radial distance(s) may be in the range from 25 mm to 50 mm, such as about 30 mm.

The first electrode may form an open loop. The second electrode may form an open loop and/or the third electrode may form an open loop. The fourth electrode may form an open loop. The fifth electrode may form an open loop. Open loop electrode(s) enables electrode arrangement in few or a single electrode layer.

The base plate may comprise a second adhesive layer, wherein the plurality of electrodes is arranged between the first adhesive layer and the second adhesive layer.

The electrode assembly may comprise a support layer, also denoted a support film. One or more electrodes may be formed, e.g. printed, on the proximal side of the support layer. One or more electrodes may be formed, e.g. printed, on the distal side of the support layer. Thus, one or more electrodes may be arranged between the support layer and the first adhesive layer. The electrode assembly may have a stomal opening with a center point.

The support layer may comprise polymeric (e.g. polyurethane, PTFE, PVDF) and/or ceramic (e.g. alumina, silica) materials. In one or more exemplary base plates, the support layer is made of thermoplastic polyurethane (TPU). The support layer material may be made of or comprise one or more of polyester, a thermoplastic elastomer (TPE), polyamide, polyimide, Ethylene-vinyl acetate (EVA), polyurea, and silicones.

Exemplary thermoplastic elastomers of the support layer are styrenic block copolymers (TPS, TPE-s), thermoplastic polyolefin elastomers (TPO, TPE-o), thermoplastic Vulcanizates (TPV, TPE-v), thermoplastic polyurethanes (TPU), thermoplastic copolyester (TPC, TPE-E), and thermoplastic polyamides (TPA, TPE-A).

The electrode assembly/base plate may comprise a masking element configured to insulate at least parts of the electrodes from the first adhesive layer of the base plate. The masking element may comprise one or more, such as a plurality of, sensor point openings. The sensor point openings may comprise primary sensor point openings and/or secondary sensor point openings. The sensor point openings may comprise tertiary sensor point opening(s). The sensor point openings may comprise quaternary sensor point opening(s) A sensor point opening of the masking element overlaps at least one electrode of the electrode assembly when seen in the axial direction, e.g. to form a sensor point. For example, a primary sensor point opening may overlap a (sensing) part of the ground electrode and/or a (sensing) part of the fourth electrode. A secondary sensor point opening may overlap a (sensing) part of the fourth electrode and/or a (sensing) part of the fifth electrode. A tertiary sensor point opening may overlap a (sensing) part of the fifth electrode and/or a (sensing) part of the ground electrode.

The masking element may comprise one or more, such as a plurality of, terminal openings. A terminal opening may overlap with one or more connection parts of electrodes. In one or more exemplary base plates, each terminal opening overlaps with a single connection part of an electrode.

The masking element may comprise polymeric (e.g. polyurethane, PTFE, PVDF) and/or ceramic (e.g. alumina, silica) materials. In one or more exemplary base plates, the masking element is made of or comprises thermoplastic polyurethane (TPU). In one or more exemplary base plates, the masking element is made of or comprises polyester. The masking element material may be made of or comprise one or more of polyester, a thermoplastic elastomer (TPE), polyimide, polyimide, Ethylene-vinyl acetate (EVA), polyurea, and silicones.

Exemplary thermoplastic elastomers of the masking element are styrenic block copolymers (TPS, TPE-s), thermoplastic polyolefin elastomers (TPO, TPE-o), thermoplastic Vulcanizates (TPV, TPE-v), thermoplastic polyurethanes (TPU), thermoplastic copolyester (TPC, TPE-E), and thermoplastic polyamides (TPA, TPE-A).

The base plate may comprise a first intermediate element. The first intermediate element may be arranged between the electrodes/electrode layer and the first adhesive layer and/or between the second layer and the first adhesive layer. The first intermediate layer may be made of an insulating material.

The base plate may comprise a release liner. The release liner is a protective layer that protects adhesive layer(s) during transport and storage and is peeled off by the user prior to applying the base plate on the skin. The release liner may have a stomal opening with a center point.

The base plate may comprise a top layer. The top layer is a protective layer protecting the adhesive layer(s) from external strains and stress when the user wears the ostomy appliance. The electrodes, e.g. some or all the electrodes, may be arranged between the first adhesive layer and the top layer. The top layer may have a stomal opening with a center point. The top layer may have a thickness in the range from 0.01 mm to 1.0 mm, e.g. in the range from 0.02 mm to 0.2 mm, such as 0.04 mm. The top layer may have a stomal opening with a center point.

The base plate comprises a monitor interface. The monitor interface may be configured for electrically and/or mechanically connecting the ostomy appliance (base plate) to the monitor device. The monitor interface may be configured for wirelessly connecting the ostomy appliance (base plate) to the monitor device. Thus, the monitor interface of the base plate is configured to electrically and/or mechanically couple the ostomy appliance and the monitor device.

The monitor interface of the base plate may comprise, e.g. as part of a first connector of the monitor interface, a coupling part for forming a mechanical connection, such as a releasable coupling between the monitor device and the base plate. The coupling part may be configured to engage with a coupling part of the monitor device for releasably coupling the monitor device to the base plate.

The monitor interface of the base plate may comprise, e.g. as part of a first connector of the monitor interface, a plurality of terminals, such as two, three, four, five, six, seven or more terminals, for forming electrical connections with respective terminals of the monitor device. The monitor interface may comprise a ground terminal element forming a ground terminal. The monitor interface may comprise a first terminal element forming a first terminal, a second terminal element forming a second terminal and optionally a third terminal element forming a third terminal. The monitor interface may comprise a fourth terminal element forming a fourth terminal and/or a fifth terminal element forming a fifth terminal. The monitor interface optionally comprises a sixth terminal element forming a sixth terminal. The terminal elements of the monitor interface may contact respective electrodes (connection parts) of the base plate/electrode assembly. The first intermediate element may be arranged between the terminal elements and the first adhesive layer. The first intermediate element may cover or overlap terminal element(s) of the base plate when seen in the axial direction. Thus, the first adhesive layer may be protected or experience more evenly distributed mechanical stress from the terminal elements of the base plate, in turn reducing the risk of terminal elements penetrating or otherwise damaging the first adhesive layer. The first intermediate element may protect or mechanically and/or electrically shield the first adhesive layer from the terminal elements of the base plate.

A terminal element, such as the ground terminal element, the first terminal element, the second terminal element, the third terminal element, the fourth terminal element, the fifth terminal element and/or the sixth terminal element, may comprise a distal end and a proximal end. A terminal element, such as the ground terminal element, the first terminal element, the second terminal element, the third terminal element, the fourth terminal element, the fifth terminal element and/or the sixth terminal element, may comprise a distal part, a centre part, and/or a proximal part. The distal part may be between the distal end and the centre part. The proximal part may be between the proximal end and the centre part. The proximal end/proximal part of a terminal element may contact a connection part of an electrode. A terminal element, such as the ground terminal element, the first terminal element, the second terminal element, the third terminal element, the fourth terminal element, the fifth terminal element and/or the sixth terminal element, may be gold plated copper.

The base plate may comprise a coupling ring or other coupling member for coupling an ostomy pouch to the base plate (two-part ostomy appliance). The center point may be defined as a center of the coupling ring.

The base plate has a stomal opening with a center point. The size and/or shape of the stomal opening is typically adjusted by the user or nurse before application of the ostomy appliance to accommodate the user's stoma. In one or more exemplary base plates, the user forms the stomal opening during preparation of the base plate for application.

The monitor device comprises a processor and one or more interfaces, such as a first interface and/or a second interface. The monitor device may comprise a memory for storing ostomy data.

The monitor device comprises a processor. The processor controls the operation of the monitor device including collection and processing of ostomy data from the base plate of the ostomy appliance, processing of, such as storing, sensor data from sensor unit, and generation/transmission of monitor data to accessory devices. The monitor device comprises a monitor device housing optionally made of a plastic material. The monitor device housing may be an elongate housing having a first end and a second end. The monitor device housing may have a length or maximum extension along a longitudinal axis in the range from 1 cm to 10 cm. The monitor device housing may have a width or maximum extension perpendicular to the longitudinal axis in the range from 0.5 cm to 5 cm, such as from 0.8 cm to 3 cm. The monitor device housing may be curve-shaped.

The monitor device housing may have a plurality of sensor openings, e.g. a plurality of sensor openings for a sensor and/or a sensor opening for each of a plurality of sensors. The monitor device may comprise one or more sensor openings in a distal surface of the monitor device. The monitor device may comprise one or more sensor openings in a side surface of the monitor device. The monitor device may comprise one or more sensor openings in an end surface of the monitor device.

The sensor opening in the proximal surface is arranged at a sensor opening distance from the first end. The sensor opening distance, also denoted D_S, may be in the range from 0.25 L to 0.75 L, such as from 0.35 L to 0.65 L, where L is the length of the monitor device housing. The sensor opening distance may be in the range from 10 mm to 70 mm.

The monitor device housing comprises or forms a sensor path from surroundings of the proximal surface to the first sensor surface. The sensor path translates temperature and/or humidity at the proximal surface of the monitor device/monitor device housing to the first sensor surface. The sensor opening forms a part of the sensor path and has a cross-sectional area optionally in the range from 0.2 mm² to 10 mm². The sensor opening may be a circular sensor opening with a diameter in the range from 0.3 mm to 1.4 mm, e.g. from 0.6 mm to 1.0 mm.

The monitor device comprises a sensor unit with one or more sensors including a first sensor. The sensor unit is connected to the processor for feeding sensor data to the processor. The sensor unit may comprise a humidity sensor for provision of humidity data to the processor. Thus, the sensor data may comprise humidity data. For example, the first sensor may be a humidity sensor for provision of humidity data to the processor. Thus, the present disclosure enables humidity detection near the skin of a user and/or on the distal side of the base plate, which in turn can be used for a more accurate estimation of base plate operation state.

The sensor unit may comprise a temperature sensor for provision of temperature data to the processor. Thus, the sensor data may comprise temperature data. For example, the first sensor may be a temperature sensor for provision of temperature data to the processor. Thus, the present disclosure enables temperature detection near the skin of a user and/or on the distal side of the base plate, which in turn can be used for a more accurate estimation of base plate operation state.

The first sensor may be a combined humidity and temperature sensor for provision of humidity and temperature data to the processor.

The sensor unit of the monitor device may comprise a second sensor, e.g. an accelerometer for provision of acceleration data to the processor. The sensor unit of the monitor device may comprise a third sensor, e.g. a gyroscope for provision of gyroscope data to the processor. The sensor unit of the monitor device may comprise a fourth sensor, e.g. a magnetometer for provision of magnetometer data to the processor.

The processor is configured for processing ostomy data obtained from the base plate and generate or determine monitor data that are transmitted to an accessory device. The monitor data may comprise sensor data obtained from the sensor unit.

The monitor device comprises a first interface for connecting the monitor device to the base plate. The first interface may be arranged in the proximal surface of the monitor device housing. The first interface may be arranged within a first interface distance from the first end. The first interface distance may be less than 0.50 L, such as less than 0.4 L, where L is the length of the monitor device housing.

The monitor device may comprise a sealing element forming a seal between the first sensor and a housing part of the monitor device housing. The sealing element may be an O-ring, e.g. made of a rubber material. The sealing element may encircle the first sensor surface to expose the first sensor surface (membrane) to the sensor path while providing a closed cavity of the monitor device, the closed cavity accommodating PCB, processor, and other electronic circuitry. A glue may form the sealing element.

The ostomy system enables a reliable and accurate measurement of different parameters relevant for monitoring of the ostomy appliance (e.g., monitoring of the base plate). In the ostomy system, a distance between the proximal surface of the monitor device and a distal surface of the base plate, in a coupled state, is in the range from 0.2 mm to 10 mm, such as in the range from 0.5 mm to 5 mm. In the coupled state, the monitor device is attached to the base plate and arranged in its intended position during use of the ostomy system.

The monitor device comprises a first interface connected to the processor. The first interface may be configured as an appliance interface for electrically and/or mechanically connecting the monitor device to the ostomy appliance. Thus, the appliance interface is configured to electrically and/or mechanically couple the monitor device and the ostomy appliance. The first interface may be configured as an accessory device interface for electrically and/or mechanically connecting the monitor device to an accessory device, such as a docking station. The first interface may be configured for coupling to a docking station of the ostomy system, e.g. for charging the monitor device and/or for data transfer between the monitor device and the docking station.

The first interface of the monitor device may comprise a plurality of terminals, such as two, three, four, five, six, seven or more terminals, for forming electrical connections with respective terminals and/or electrodes of the ostomy appliance. One or more terminals of the first interface may be configured for forming electrical connections with an accessory device, e.g. with respective terminals of a docking station. The first interface may comprise a ground terminal. The first interface may comprise a first terminal, a second terminal and optionally a third terminal. The first interface may comprise a fourth terminal and/or a fifth terminal. The first interface optionally comprises a sixth terminal. In one or more exemplary monitor devices, the first interface has M terminals, wherein M is an integer in the range from 4 to 8.

The first interface of the monitor device may comprise a coupling part for forming a mechanical connection, such as a releasable coupling between the monitor device and the base plate. The coupling part and the terminals of the first interface form (at least part of) a first connector of the monitor device.

The monitor device comprises a power unit for powering the monitor device. The power unit may comprise a battery. The power unit may comprise charging circuitry connected to the battery and terminals of the first interface for charging the battery via the first interface, e.g. the first connector. The first interface may comprise separate charging terminal(s) for charging the battery.

The monitor device comprises a second interface connected to the processor. The second interface may be configured as an accessory interface for connecting, e.g. wirelessly connecting, the monitor device to one or more accessory devices. The second interface may comprise an antenna and a wireless transceiver, e.g. configured for wireless communication at frequencies in the range from 2.4 to 2.5 GHz. The wireless transceiver may be a Bluetooth transceiver, i.e. the wireless transceiver may be configured for wireless communication according to Bluetooth protocol, e.g. Bluetooth Low Energy, Bluetooth 4.0, Bluetooth 5. The second interface optionally comprises a loudspeaker and/or a haptic feedback element for provision of an audio signal and/or haptic feedback to the user, respectively. The processor may be configured to transmit monitor data, as a wireless monitor signal via the antenna and the wireless transceiver.

The ostomy system may comprise a docking station forming an accessory device of the ostomy system. The docking station may be configured to electrically and/or mechanically couple the monitor device to the docking station.

The docking station may comprise a docking monitor interface. The docking monitor interface may be configured for electrically and/or mechanically connecting the monitor device to the docking station. The docking monitor interface may be configured for wirelessly connecting the monitor device to the docking station. The docking monitor interface of the docking station may be configured to electrically and/or mechanically couple the docking station and the monitor device.

The docking monitor interface of the docking station may comprise, e.g. as part of a first connector of the docking monitor interface, a coupling part for forming a mechanical connection, such as a releasable coupling between the monitor device and the docking station. The coupling part may be configured to engage with a coupling part of the monitor device for releasably coupling the monitor device to the docking station.

The docking monitor interface of the docking station may comprise, e.g. as part of a first connector of the docking monitor interface, a plurality of terminals, such as two, three, four, five, six, seven or more terminals, for forming electrical connections with respective terminals of the monitor device. The docking monitor interface may comprise a ground terminal. The docking monitor interface may comprise a first terminal and/or a second terminal. The docking station may comprise a third terminal. The docking monitor interface may comprise a fourth terminal and/or a fifth terminal. The docking monitor interface optionally comprises a sixth terminal.

The accessory device comprises a memory, a processor and an interface coupled to the processor. The interface comprises a display, such as a touch-sensitive display

The interface of the accessory device is configured to communicate with monitor device and/or server device. The interface of the accessory device may be configured to communicate with server device via a network.

The interface of the accessory device may be configured as a monitor interface for connecting, e.g. wirelessly connecting, the accessory device to one or more monitor devices. The interface of the accessory device may comprise an antenna and a wireless transceiver, e.g. configured for wireless communication at frequencies in the range from 2.4 to 2.5 GHz. The wireless transceiver may be a Bluetooth transceiver, i.e. the wireless transceiver may be configured for wireless communication according to Bluetooth protocol, e.g. Bluetooth Low Energy, Bluetooth 4.0, Bluetooth 5.

The accessory device is configured to receive monitor data from one or more monitor devices. The accessory device may be configured to transmit accessory data, e.g. to a server device. For example, the processor of the accessory device may be configured to transmit accessory data, as a wireless accessory signal via the antenna and the wireless transceiver.

The interface of the accessory device comprises a display and is configured to obtain monitor data from the monitor device coupled to the ostomy appliance. The monitor data may comprise sensor data obtained from one or more sensors in the monitor device. The monitor data may comprise ostomy data obtained from electrodes of the base plate, and/or parameter data based on ostomy data obtained from electrodes of the base plate.

The monitor data may be indicative of a condition of the ostomy appliance, e.g. a condition of the base plate disclosed herein. The condition of the ostomy appliance or of the base plate disclosed herein may refer to a level of a physical property of at least a part of the ostomy appliance, such as a level of moisture and/or temperature of at least a part of the base plate, such as a level of a physical property of at least a layer of the base plate, such as a level of moisture and/or temperature of at least a layer of the base plate, such as a level of a physical property of at least an adhesive layer of the base plate (e.g. a first adhesive layer proximal to the skin of the user). In one or more exemplary accessory devices, the interface is configured to obtain the monitor data by obtaining the monitor data indicative of the condition comprising a moisture level of a first adhesive layer of the base plate and/or a moisture level of a proximal side of the first adhesive layer. The moisture level may be seen as representative of a conductive path in the first adhesive layer, such as across the first adhesive layer. The monitor data comprises e.g. data representative of the measurement of the electrical properties of the first adhesive layer. In other words, the condition may be seen as a condition of the first adhesive layer.

A user interface refers herein to a graphical representation comprising a collection of user interface objects. A user interface comprises one or more user interface objects. A user interface may be referred to as a user interface screen.

A user interface object refers herein to a graphical representation of an object that is displayed on the display of the accessory device. The user interface object may be user-interactive, or selectable by a user input. For example, an image (e.g., icon), a button, and text (e.g., hyperlink) each optionally constitute a user interface object. The user interface object may form part of a widget. A widget may be seen as a mini-application that may be used by the user, and created by the user. A user interface object may comprise a prompt, application launch icon, and/or an action menu. An input, such as first input and/or second input, may comprise a touch (e.g. a tap, a force touch, a long press), a and/or movement of contact (e.g. a swipe gesture, e.g. for toggling). The movement on contact may be detected by a touch sensitive surface, e.g. on a display of an accessory device. Thus, the display may be a touch sensitive display. An input, such as first input and/or second input, may comprise a lift off. An input, such as first input and/or second input, may comprise a touch and a movement followed by a lift off.

The display of the accessory device may be configured to detect touch (e.g. the display is a touch-sensitive display), the input comprises a contact on the touch sensitive display. A touch-sensitive display provides an input interface and an output interface between the accessory device and a user. A processor of the accessory device may be configured to receive and/or send electrical signals from/to touch-sensitive display. A touch-sensitive display is configured to display visual output to the user. The visual output optionally includes graphics, text, icons, video, and any combination thereof (collectively termed “graphics”). For example, some or all of the visual output may be seen as corresponding to user-interface objects.

The processor of the accessory device may be configured to display, on the display, one or more user interfaces, such as user interface screens, including a first user interface and/or a second user interface. A user interface may comprise one or more, such as a plurality of user interface objects. For example, the first user interface may comprise a first primary user interface object and/or a first secondary user interface object. A second user interface may comprise a second primary user interface object and/or a second secondary user interface object. A user interface object, such as the first primary user interface object and/or the second primary user interface object, may represent an operating state of the base plate.

An operating state in the present disclosure is indicative of the dynamic internal state of the ostomy appliance (e.g. of the base plate of the ostomy appliance currently being worn by the user) optionally related to adhesive performance of the ostomy appliance. Adhesive performance of the ostomy appliance may be related to an internal condition of the ostomy appliance (e.g. of the base plate of the ostomy appliance), such as an internal condition of an adhesive layer of the ostomy appliance. The adhesive performance, and thereby the operating state may be affected by several factors, such as humidity, temperature, misplacement of the ostomy appliance on the stoma, and/or malfunction of the ostomy appliance. The one or more factors alone or in combination impact the adhesive performance of the ostomy appliance. The operating state may be varying in time. The operating state may be indicative of a degree of erosion of the base plate.

Adhesive performance may be indicative of wear property, e.g. wear time and/or wear comfort. The operating state may comprise at least one of: a wear time, a quality of adhesion, and a moisture pattern representation. Wear time may comprise average wear time, nominal wear time, minimal wear time, maximal wear time, median wear time, and/or any of other statistical metric derivable from wear time. Wear time may comprise remaining wear time and/or current wear time and/or elapsed wear time. A quality of adhesion may comprise a metric indicative of erosion of a layer of the base plate, such as of the first adhesive layer. A moisture pattern representation may comprise one or more metrics or parameters representative or indicative of a moisture pattern (e.g. a moisture pattern type), e.g. a moisture pattern of the first adhesive layer.

An operating state may be configured to indicate whether the ostomy appliance is properly operational based on its adhesive performance (e.g. wear property, e.g. wear time and/or wear comfort). For example, the operating state may be indicative of the severity and/or imminence of a leakage (e.g. low, medium, acute). The operating state may comprise Z operating states, where Z is an integer. The operating state may comprise a first operating state, a second operating state, and/or a third operating state (e.g. good, check, change in X time/NOW).

In one or more exemplary monitor devices, the processor is configured to apply a processing scheme, the first interface is connected to the processor and the memory, and the first interface is configured for collecting ostomy data from the base plate coupled to the first interface. The ostomy data may comprise one or more, such as all, of first ostomy data from a first electrode pair of the base plate, second ostomy data from a second electrode pair of the base plate, and third ostomy data from a third electrode pair of the base plate. A second interface is connected to the processor. To apply a processing scheme may comprise one or more of obtain first parameter data based on the first ostomy data; obtain second parameter data based on the second ostomy data; and obtain third parameter data based on the third ostomy data. To apply a processing scheme may comprise determine an operating state of the base plate of the ostomy appliance based on one or more, such as all, of the first parameter data, the second parameter data and the third parameter data. The operating state may be indicative of a degree of radial erosion of the base plate, such as of the first adhesive layer, and/or an acute leakage risk for the ostomy appliance. The monitor device is configured to, in accordance with a determination that the operating state is a first operating state, transmit a first monitor signal comprising monitor data indicative of the first operating state of the base plate via the second interface; and/or in accordance with a determination that the operating state is a second operating state, transmit a second monitor signal comprising monitor data indicative of the second operating state of the base plate via the second interface.

In one or more exemplary monitor devices, the first operating state of the base plate corresponds to a situation wherein the first adhesive layer of the base plate has experienced a first degree of radial erosion, e.g. the first adhesive layer is eroded to a first radial distance of the first electrode pair but not to a second radial distance of the second electrode pair.

In one or more exemplary monitor devices, the second operating state of the base plate corresponds to a situation wherein the first adhesive layer of the base plate has experienced a second degree of radial erosion, e.g. the first adhesive layer is eroded to the second radial distance of the second electrode pair but not to a third radial distance of the third electrode pair.

To obtain first parameter data based on the first ostomy data may comprise determining one or more first parameters based on the first ostomy data. To obtain second parameter data based on the second ostomy data may comprise determining one or more second parameters based on the second ostomy data. To obtain third parameter data based on the third ostomy data may comprise determining one or more third parameters based on the third ostomy data. In one or more exemplary monitor devices, determination of an operating state may be based on one or more first parameters, such as first primary parameter and/or first secondary parameter of first parameter data. In one or more exemplary monitor devices, determination of an operating state may be based on one or more second parameters, such as second primary parameter and/or second secondary parameter of the second parameter data. In one or more exemplary monitor devices, determination of an operating state may be based on one or more third parameters, such as third primary parameter and/or third secondary parameter of the third parameter data.

In one or more exemplary monitor devices, determination of an operating state may be based on one or more fourth parameters, such as fourth primary parameter and/or fourth secondary parameter of the fourth parameter data.

The first parameter data, the second parameter data, and the third parameter data may be indicative of resistance between the first electrode pair, the second electrode pair, and the third electrode pair, respectively. The first parameter data, the second parameter data, and the third parameter data may be indicative of voltage between the first electrode pair, the second electrode pair, and the third electrode pair, respectively (and thus indicative of resistance). The first parameter data, the second parameter data, and the third parameter data may be indicative of current between the first electrode pair, the second electrode pair, and the third electrode pair, respectively (and thus indicative of resistance).

The first parameter data, the second parameter data, and the third parameter data may be indicative of a rate of change in resistance between the first electrode pair, the second electrode pair, and the third electrode pair, respectively. In one or more exemplary monitor devices, the first parameter data, the second parameter data, and the third parameter data may be indicative of a rate of change in voltage between the first electrode pair, the second electrode pair, and the third electrode pair, respectively. In one or more exemplary monitor devices, the first parameter data, the second parameter data, and the third parameter data may be indicative of a rate of change in current between the first electrode pair, the second electrode pair, and the third electrode pair, respectively.

In one or more exemplary monitor devices, to determine an operating state of the base plate is based on a first criteria set based on the first parameter data and/or the second parameter data, wherein the operating state is determined to be the first operating state if the first criteria set is satisfied. The first criteria set may comprise one or more first criteria based on one or more of first parameter data, second parameter data and third parameter data. The first criteria set may comprise a first primary criterion based on the first parameter data. The first criteria set may comprise a first secondary criterion based on the second parameter data. The first criteria set may comprise a first tertiary criterion based on the third parameter data.

In one or more exemplary monitor devices, to determine an operating state of the base plate may be based on a first threshold set comprising one or a plurality of first threshold values. The first threshold set may comprise one or a plurality of threshold values, e.g. to be applied in the first criteria set. The first threshold set may comprise a first primary threshold value. The first threshold set may comprise a first secondary threshold value. The first threshold set may comprise a first tertiary threshold value.

The first criteria set may be given by or at least may comprise

(P_1_1<TH_1_1),

(P_2_1>TH_1_2), and

(P_3_1>TH_1_3),

wherein P_1_1 is a first primary parameter based on the first parameter data, TH_1_1 is a first primary threshold value, P_2_1 is a second primary parameter based on the second parameter data, TH_1_2 is a first secondary threshold value, P_3_1 is a third primary parameter based on the third parameter data, and TH_1_3 is a first tertiary threshold value, and wherein the first operating state is indicative of low degree of radial erosion on the base plate. The first threshold values (TH_1_1, TH_1_2 and TH_1_3) may be the same or different, e.g. depending on the electrode configuration of the base plate. The first tertiary criterion (P_3_1<TH_1_3) may be omitted in the first criteria set. The first operating state, e.g. indicative of low degree of radial erosion on the base plate may be indicative of a radial progression of moisture to the first electrode pair (but not to the second electrode pair and not to the third electrode pair) which corresponds to e.g. an un-alarming and/or normal radial progression of moisture.

In one or more exemplary embodiments, when the first parameter data, the second parameter data and the third parameter data are each respectively indicative of resistance between the first electrode pair, the second electrode pair and the third electrode pair respectively, the first threshold values (TH_1_1, TH_1_2 and TH_1_3) may correspond to first resistance threshold values. In one or more exemplary embodiments, the first primary threshold value TH_1_1 may correspond to an upper resistance threshold value. An upper resistance threshold value may be set to a value which is less than 30 Mega-Ohms, such as 25 Mega-Ohms, such as 20.5 Mega-Ohms, such as 20.4 Mega-Ohms. In one or more exemplary embodiments, the first secondary threshold value TH_1_2 may correspond to the upper resistance threshold value. In one or more exemplary embodiments, the first tertiary threshold value TH_1_3 may correspond to the upper resistance threshold value. The first primary parameter P_1_1 may be indicative of the resistance between the first electrode pair (first electrode and first electrode part of the ground electrode) of the base plate. The first parameter data may comprise a first secondary parameter which may be derived from the first primary parameter, and/or a first tertiary parameter, which may be derived from the first primary parameter. A first secondary parameter P_1_2 may comprise or be a gradient derived from the first primary parameter. In one or more embodiments, a first primary parameter P_1_1 may be indicative of a voltage between the first electrode pair (first electrode and first electrode part of the ground electrode) of the base plate.

In one or more exemplary embodiments, when the first parameter data, the second parameter data and the third parameter data are each respectively indicative of voltage between the first electrode pair, the second electrode pair and the third electrode pair respectively, the first threshold values (TH_1_1, TH_1_2 and TH_1_3) may correspond to first voltage threshold values. In one or more exemplary embodiments, the first primary threshold value TH_1_1 may correspond to an upper voltage threshold value. An upper voltage threshold value may be set to a value less than 5 Volts, such as 3 Volts, such as 2, 86 Volts. In one or more exemplary embodiments, the first secondary threshold value TH_1_2 may correspond to the upper voltage threshold value. In one or more exemplary embodiments, the first tertiary threshold value TH_1_3 may correspond to the upper voltage threshold value.

The first criteria set may comprise e.g.

(P_4_1>TH_1_4)

wherein P_4_1 is a fourth primary parameter based on the fourth parameter data and indicative of the resistance, voltage, or current between the fourth electrode pair and TH_1_4 is a first quaternary threshold value, and wherein the first operating state is indicative of absence of fluid on the proximal side of the first adhesive layer of the base plate of the ostomy appliance. In one or more exemplary embodiments, the first quaternary threshold value TH_1_4 may correspond to an upper resistance threshold value. An upper resistance threshold value may be set to a value which is less than 30 Mega-Ohms, such as 25 Mega-Ohms, such as 20.5 Mega-Ohms, such as 20.4 Mega-Ohms.

In one or more exemplary embodiments, the following additional criterion may be determined

(P_1_1<TH_low),

wherein P_1_1 is a first primary parameter based on the first parameter data, TH_low is a threshold value corresponding to a lower resistance threshold value. In one or more exemplary embodiments, a lower resistance threshold value may be set to a value less than 1 Mega-Ohms, such as 100 kilo-Ohms, such as 80 kilo-Ohms, such as 79 kilo-Ohms. This is indicative of a saturation of the first electrode pair by the moisture detected and there are no further changes expected by the first primary parameter. Moisture is likely to continue its progression.

In one or more exemplary embodiments, the following additional criterion may be determined

(P_2_1<TH_low),

wherein P_2_1 is a second primary parameter based on the second parameter data, TH_low is a threshold value corresponding to a lower resistance threshold value. In one or more exemplary embodiments, a lower resistance threshold value may be set to a value less than 1 Mega-Ohms, such as 100 kilo-Ohms, such as 80 kilo-Ohms, such as 79 kilo-Ohms. This is indicative of a saturation of the second electrode pair by the moisture detected and there are no further changes expected by the second primary parameter. Moisture is likely to continue its progression.

In one or more exemplary embodiments, the following additional criterion may be determined:

(P_3_1>TH_low),

P_3_1 is a third primary parameter based on the third parameter data, and TH_low is a threshold value corresponding to a lower resistance threshold value. In one or more exemplary embodiments, a lower resistance threshold value may be set to a value less than 1 Mega-Ohms, such as 100 kilo-Ohms, such as 80 kilo-Ohms, such as 79 kilo-Ohms. This is indicative of a saturation of the third electrode pair by the moisture detected and there are no further changes expected by the second primary parameter. Moisture is likely to continue its progression.

In one or more exemplary embodiments, one or more criteria of a criteria set, e.g. one or more first criteria of the first criteria set and/or one or more second criteria of the second criteria set, may be based on timing information or one or more delay parameters based on the parameter data. In one or more exemplary embodiments, one or more delay parameters or time differences related to different parameter data, e.g. related to the first parameter data and the second parameter data, are determined.

In one or more exemplary embodiments, one or more first criteria of the first criteria set may be based on timing information (e.g. one or more delay parameters of the parameter data and/or one or more times where a parameter crosses a threshold).

In one or more exemplary embodiments, the timing information may comprise a time difference D_1_2_1 between a time T1 where P_1_1 crosses a threshold, such as TH_1_1, and a time T2 where P_2_1 crosses a threshold, such as TH_1_2. Thus, delay parameter or time difference D_1_2_1 may be given as D_1_2_1=T2−T1.

In one or more exemplary embodiments, the timing information, e.g. used in the first criteria set, may comprise a time difference D_2_3_1 between a time T2 where P_2_1 crosses a threshold, such as TH_1_2, and a time T3 where P_3_1 crosses a threshold, such as TH_1_3. Thus, delay parameter or time difference D_2_3_1 may be given as D_2_3_1=T3−T2.

In one or more exemplary embodiments, one or more criteria sets, such as the third criteria set and/or the second criteria set, may comprise any of:

D_1_2_1>Z

D_2_3_1>Z

Wherein Z is a time difference constant characterizing the progression of moisture (e.g. 3 h, e.g. 2 h). Different time difference constants may be employed in different criteria sets/for different time delays.

In one or more exemplary embodiments, one or more criteria sets, such as the second criteria set and/or the third criteria set may comprise any of:

D_1_2_1>Z

Wherein Z is a time difference constant characterizing the progression of moisture (e.g. 3 h, e.g. 2 h).

The second primary parameter may be indicative of the resistance between the second electrode pair (second electrode and second electrode part of the ground electrode) of the base plate.

The second parameter data may comprise a second secondary parameter, and/or a second tertiary parameter, which may be derived from the second primary parameter. A second secondary parameter may be indicative of a voltage between the second electrode pair (second electrode and second electrode part of the ground electrode) of the base plate.

The third primary parameter may be indicative of resistance between the third electrode pair (third electrode and third electrode part of the ground electrode) of the base plate.

The third parameter data may comprise a third secondary parameter, and/or a third tertiary parameter, which may be derived from the third primary parameter. A third secondary parameter may be indicative of a voltage between the second electrode pair (second electrode and second electrode part of the ground electrode) of the base plate.

In one or more exemplary monitor devices, to determine an operating state of the base plate is based on a second criteria set based on the second parameter data and/or the third parameter data, wherein the operating state is determined to be the second operating state if the second criteria set is satisfied. The second criteria set may be based on the first parameter data.

The second criteria set may comprise one or more second criteria based on one or more of first parameter data, second parameter data and third parameter data. The second criteria set may comprise a second primary criterion based on the first parameter data. The second criteria set may comprise a second secondary criterion based on the second parameter data. The second criteria set may comprise a second tertiary criterion based on the third parameter data.

In one or more exemplary monitor devices, to determine an operating state of the base plate is based on a second threshold set comprising one or a plurality of second threshold values. The second threshold set may comprise one or a plurality of threshold values, e.g.

to be applied in the second criteria set. The second threshold set may comprise a second primary threshold value. The second threshold set may comprise a second secondary threshold value. The second threshold set may comprise a second tertiary threshold value.

The second criteria set may be given by or at least may comprise

(P_1_1<TH_2_1),

(P_2_1<TH_2_2), and

(P_3_1>TH_2_3)

wherein P_1_1 is a first primary parameter based on the first parameter data and indicative of the resistance between the first electrode pair, TH_2_1 is a second primary threshold value, P_2_1 is a second primary parameter based on the second parameter data and indicative of the resistance between the second electrode pair, TH_2_2 is a second secondary threshold value, P_3_1 is a third primary parameter based on the third parameter data and indicative of the resistance between the third electrode pair, TH_2_3 is a second tertiary threshold value, and wherein the second operating state is indicative of medium degree of radial erosion on the base plate. The second threshold values (TH_2_1, TH_2_2 and TH_2_3) may be the same or different, e.g. depending on the electrode configuration of the base plate. The second primary criterion (P_1_1<TH_2_1) and/or the second tertiary criterion (P_3_1>TH_2_3) may be omitted in the second criteria set. The second operating state indicative of medium degree of radial erosion on the base plate may be indicative of a radial progression of moisture to the first electrode pair and the second electrode pair (and not the third electrode pair). The second operating state indicative of medium degree of radial erosion on the base plate may be indicative of a radial progression of moisture to the first electrode pair and to the second electrode pair. In one or more exemplary embodiments, when the first parameter data, the second parameter data and the third parameter data are each respectively indicative of resistance between the first electrode pair, the second electrode pair and the third electrode pair respectively, the second threshold values (TH_2_1, TH_2_2 and TH_2_3) may correspond to second resistance threshold values. In one or more exemplary embodiments, the second primary threshold value TH_2_1 may correspond to an upper resistance threshold value. An upper resistance threshold value may be set to a value which is less than 30 Mega-Ohms, such as 25 Mega-Ohms, such as 20.5 Mega-Ohms, such as 20.4 Mega-Ohms. In one or more exemplary embodiments, the second secondary threshold value TH_2_2 may correspond to the upper resistance threshold. In one or more exemplary embodiments, the second tertiary threshold value TH_2_3 may correspond to the upper resistance threshold value. In one or more exemplary embodiments, the second primary threshold value TH_2_1 may correspond to a medium resistance threshold value. A medium resistance threshold value may be set to a value less than 10 Mega-Ohms, such as 5 Mega-Ohms, such as 3 Mega-Ohms, such as 2 Mega-Ohms, such as 1 Mega-Ohms.

In one or more exemplary embodiments, when the first parameter data, the second parameter data and the third parameter data are each respectively indicative of voltage between the first electrode pair, the second electrode pair and the third electrode pair respectively, the second threshold values (TH_2_1, TH_2_2 and TH_2_3) may correspond to second voltage threshold values. In one or more exemplary embodiments, the second primary threshold value TH_2_1 may correspond to an upper voltage threshold value. An upper voltage threshold value may be set to a value less than 5 Volts, such as 3 Volts, such as 2.86 Volts. In one or more exemplary embodiments, the second secondary threshold value TH_2_2 may correspond to the upper voltage threshold value. In one or more exemplary embodiments, the second tertiary threshold value TH_2_3 may correspond to the upper voltage threshold value. In one or more exemplary embodiments, the second primary threshold value TH_2_1 may correspond to a medium voltage threshold value. A medium resistance threshold value may be set to a value less than 10 Mega-Ohms, such as 5 Mega-Ohms, such as 3 Mega-Ohms, such as 2 Mega-Ohms, such as 1 Mega-Ohms.

In one or more exemplary embodiments, the second criteria set may comprise any of:

D_1_2_1>Z

Wherein Z is a time difference constant characterizing the progression of moisture (e.g. 3 h, e.g. 2 h).

In one or more exemplary monitor devices, to determine an operating state of the base plate is based on a default criteria set based on the first parameter data, wherein the operating state is determined to be the default operating state if the default criteria set is satisfied, and in accordance with a determination that the operating state is the default operating state, transmit a default monitor signal comprising monitor data indicative of the default operating state of the ostomy appliance (e.g., operating state of the base plate).

The default criteria set may be given by or at least may comprise

(P_1_1>TH_D_1),

(P_2_1>TH_D_2), and

(P_3_1>TH_D_3)

wherein P_1_1 is a first primary parameter based on the first parameter data and indicative of the resistance between the first electrode pair, TH_D_1 is a default primary threshold value, P_2_1 is a second primary parameter based on the second parameter data and indicative of the resistance between the second electrode pair, TH_D_2 is a default secondary threshold value, P_3_1 is a third primary parameter based on the third parameter data and indicative of the resistance between the third electrode pair, TH_D_3 is a default tertiary threshold value, and wherein the default operating state is indicative of very low or no degree of radial erosion on the base plate. The default threshold values (TH_D_1, TH_D_2 and TH_D_3) may be the same or different, e.g. depending on the electrode configuration of the base plate. In one or more exemplary embodiments, when the first parameter data, the second parameter data and the third parameter data are each respectively indicative of resistance between the first electrode pair, the second electrode pair and the third electrode pair respectively, the default threshold values (TH_D_1, TH_D_2 and TH_D_3) may correspond to default resistance threshold values. In one or more exemplary embodiments, the second primary threshold value TH_D_1 may correspond to an upper resistance threshold value. An upper resistance threshold value may be set to a value which is less than 30 Mega-Ohms, such as 25 Mega-Ohms, such as 20.5 Mega-Ohms, such as 20.4 Mega-Ohms. In one or more exemplary embodiments, the default secondary threshold value TH_D_2 may correspond to the upper resistance threshold. In one or more exemplary embodiments, the default tertiary threshold value TH_D_3 may correspond to the upper resistance threshold value.

In one or more exemplary embodiments, when the first parameter data, the second parameter data and the third parameter data are each respectively indicative of voltage between the first electrode pair, the second electrode pair and the third electrode pair respectively, the default threshold values (TH_D_1, TH_D_2 and TH_D_3) may correspond to default voltage threshold values. In one or more exemplary embodiments, the default primary threshold value TH_D_1 may correspond to an upper voltage threshold value. An upper voltage threshold value may be set to a value less than 5 Volts, such as 3 Volts, such as 2.86 Volts. In one or more exemplary embodiments, the default secondary threshold value TH_D_2 may correspond to the upper voltage threshold value. In one or more exemplary embodiments, the default tertiary threshold value TH_D_3 may correspond to the upper voltage threshold value.

In one or more exemplary monitor devices, to determine an operating state of the base plate is based on a third criteria set based on the third parameter data, wherein the operating state is determined to be the third operating state if the third criteria set is satisfied, and in accordance with a determination that the operating state is the third operating state, transmit a third monitor signal comprising monitor data indicative of the third operating state of the ostomy appliance.

In one or more exemplary monitor devices, the third operating state of the base plate corresponds to a situation wherein the first adhesive layer of the base plate has experienced a third degree of radial erosion, e.g. the first adhesive layer is eroded to the third radial distance of the third electrode pair.

The third criteria set may be given by or at least may comprise:

(P_1_1<TH_3_1),

(P_2_1<TH_3_2), and

(P_3_1<TH_3_3)

wherein P_1_1 is a first primary parameter based on the first parameter data and indicative of the resistance between the first electrode pair, TH_3_1 is a third primary threshold value, P_2_1 is a second primary parameter based on the second parameter data and indicative of the resistance between the second electrode pair, TH_3_2 is a third secondary threshold value, P_3_1 is a third primary parameter based on the third parameter data and indicative of the resistance between the third electrode pair, TH_3_3 is a third tertiary threshold value, and wherein the third operating state is indicative of high degree of radial erosion on the base plate. The third threshold values (TH_3_1, TH_3_2 and TH_3_3) may be the same or different, e.g. depending on the electrode configuration of the base plate. The third primary criterion (P_1_1<TH_3_1) and/or the third secondary criterion (P_2_1<TH_3_2) may be omitted in the third criteria set. The third operating state indicative of high degree of radial erosion on the base plate may be indicative of high likelihood of leakage, e.g. on the proximal side of the base plate, e.g. within a time period e.g. within the next 20 minutes. The third operating state may indicate a radial progression of moisture to the first electrode pair, the second electrode pair, and the third electrode pair.

In one or more exemplary embodiments, when the first parameter data, the second parameter data and the third parameter data are each respectively indicative of resistance between the first electrode pair, the second electrode pair and the third electrode pair respectively, the third threshold values (TH_3_1, TH_3_2 and TH_3_3) may correspond to third resistance threshold values. In one or more exemplary embodiments, the third primary threshold value TH_3_1 may correspond to an upper resistance threshold value. In one or more exemplary embodiments, the third secondary threshold value TH_3_2 may correspond to an upper resistance threshold value. In one or more exemplary embodiments, the third tertiary threshold value TH_3_3 may correspond to an upper resistance threshold value. An upper resistance threshold value may be set to a value which is less than 30 Mega-Ohms, such as 25 Mega-Ohms, such as 20.5 Mega-Ohms, such as 20.4 Mega-Ohms.

In one or more exemplary embodiments, the third primary threshold value TH_3_1 may correspond to a lower resistance threshold value. In one or more exemplary embodiments, a lower resistance threshold value may be set to a value less than 1 Mega-Ohms, such as 100 kilo-Ohms, such as 80 kilo-Ohms, such as 79 kilo-Ohms. In one or more exemplary embodiments, the third secondary threshold value TH_3_2 may correspond to a medium resistance threshold. A medium resistance threshold value may be set to a value less than 10 Mega-Ohms, such as 5 Mega-Ohms, such as 3 Mega-Ohms, such as 2 Mega-Ohms, such as 1 Mega-Ohms. In one or more exemplary embodiments, the third tertiary threshold value TH_3_3 may correspond to the upper resistance threshold. An upper resistance threshold value may be set to a value which is less than 30 Mega-Ohms, such as 25 Mega-Ohms, such as 20.5 Mega-Ohms, such as 20.4 Mega-Ohms.

In one or more exemplary embodiments, when the first parameter data, the second parameter data and the third parameter data are each respectively indicative of voltage between the first electrode pair, the second electrode pair and the third electrode pair respectively, the third threshold values (TH_3_1, TH_3_2 and TH_3_3) may correspond to third voltage threshold values. In one or more exemplary embodiments, the third primary threshold value TH_3_1 may correspond to an upper voltage threshold value. In one or more exemplary embodiments, the third secondary threshold value TH_3_2 may correspond to an upper voltage threshold value. In one or more exemplary embodiments, the second tertiary threshold value TH_2_3 may correspond to the upper voltage threshold value.

In one or more exemplary embodiments, the third primary threshold value TH_3_1 may correspond to a lower voltage threshold value. In one or more exemplary embodiments, a lower voltage threshold value may be set to a value which is less than 1 Volt, such as 0.5 Volt, such as 0.25 Volts, such as 0.22 Volts. In one or more exemplary embodiments, the third secondary threshold value TH_3_2 may correspond to a medium voltage threshold value. A medium voltage threshold value may be set to a value less than 2 Volts, such as 1.5 Volts. In one or more exemplary embodiments, the second tertiary threshold value TH_2_3 may correspond to the upper voltage threshold value.

In one or more exemplary embodiments, the third criteria set may comprise any of:

D_1_2_1<Z

D_2_3_1<Z

Wherein Z is a time difference constant characterizing the progression of moisture (e.g. 3 h, e.g. 2 h), a time difference D_1_2_1 between a time T1 where P_1_1 crosses TH_1_1 and a time T2 where P_2_1 crosses TH_1_2, and a time difference D_2_3_1 between a time T2 where P_2_1 crosses TH_1_2 and a time T3 where P_3_1 crosses TH_1_3.

In one or more exemplary monitor devices, the ostomy data comprises fourth ostomy data from a fourth electrode pair of the base plate. To apply a processing scheme may comprise to obtain fourth parameter data based on the fourth ostomy data, and determine an operating state of the base plate of the ostomy appliance based on the fourth parameter data. The monitor device may be configured to, in accordance with a determination that the operating state is a fourth operating state, transmit a fourth monitor signal comprising monitor data indicative of the fourth operating state of the ostomy appliance.

In one or more exemplary monitor devices, the fourth operating state of the base plate corresponds to a situation, wherein the fourth electrode pair detects fluid, such as output, between the proximal surface of first adhesive layer and the skin of the user at a fourth radial distance, and thus there is a high risk of leakage from the ostomy appliance in the fourth operating state.

The fourth criteria set may be given by or at least may comprise:

(P_4_1<TH_4_4)

wherein P_4_1 is a fourth primary parameter based on the fourth parameter data and indicative of the resistance between the fourth electrode pair and TH_4_4 is a fourth quaternary threshold value, and wherein the fourth operating state is indicative of high risk of leakage from the ostomy appliance.

In one or more exemplary embodiments, the fourth quaternary threshold value TH_4_4 may correspond to an upper resistance threshold value.

In one or more exemplary monitor devices, a fifth operating state of the base plate corresponds to a situation, wherein the fourth electrode pair detects fluid, such as sweat, between the proximal surface of first adhesive layer and the skin of the user at a fourth radial distance, and thus there is a no leakage from the ostomy appliance in the fifth operating state.

The fifth operating state may be determined in accordance with a determination that one or more fifth criterion of a fifth criteria set are satisfied.

The fifth criteria set may be given by or at least may comprise:

(P_4_1<TH_5_1)

(P_4_2<TH_5_2)

(P_4_3<TH_5_3)

(∇P_4_1<V)

(∇P_4_2<V) and

(∇P_4_3<V)

Wherein P_4_1 is a fourth primary parameter based on the fourth parameter data and indicative of the resistance between the fourth electrode pair, P_4_2 is a fourth secondary parameter indicative of the resistance between the fourth electrode and the fifth electrode, P_4_3 is a fourth tertiary parameter based on the fourth parameter data and indicative of the resistance between the fifth electrode pair and TH_5_1 is a fifth primary threshold value, TH_5_2 is a fifth secondary threshold value, TH_5_3 is a fifth tertiary threshold value and VP_4_1 is gradient of P_4_1, ∇P_4_2 is gradient of P_4_2, ∇P_4_3 is gradient of P_4_3, and V is a gradient limit (e.g. 80%). In one or more exemplary embodiments, the fifth primary threshold value TH_5_1 may correspond to an upper resistance threshold value. In one or more exemplary embodiments, TH_5_2 may correspond to an upper resistance threshold value. In one or more exemplary embodiments, TH_5_3 may correspond to an upper resistance threshold value. An upper resistance threshold value may be set to a value which is less than 30 Mega-Ohms, such as 25 Mega-Ohms, such as 20.5 Mega-Ohms, such as 20.4 Mega-Ohms. The fifth operating state may refer to presence of sweat detected by the fourth parameter data indicating moisture detected omnidirectionally from the stomal opening and uniformally.

In one or more exemplary monitor devices, the sixth operating state of the base plate corresponds to a situation, wherein the fourth electrode pair detects fluid, such as output, between the proximal surface of first adhesive layer and the skin of the user at a fourth radial distance, and thus there is a sudden leakage from the ostomy appliance in the sixth operating state.

A sixth operating state may be determined in accordance with a determination that one or more sixth criteria of a sixth criteria set are satisfied by the fourth parameter data.

The sixth criteria set may comprise a sixth primary criterion, wherein the sixth primary criterion may comprise:

(P_4_1<TH_6_1) and

(∇P_4_1>V)

The sixth criteria set may comprise a sixth secondary criterion, wherein the sixth secondary criterion may comprise:

(P_4_2<TH_6_2) and

(∇P_4_2>V)

The sixth criteria set may comprise a sixth tertiary criterion, wherein the sixth tertiary criterion may comprise:

(P_4_3<TH_6_3) and

(∇P_4_3>V)

Wherein P_4_1 is a fourth primary parameter based on the fourth parameter data and indicative of the resistance between the fourth electrode pair, P_4_2 is a fourth secondary parameter indicative of the resistance between the fourth electrode and the fifth electrode, P_4_3 is a fourth tertiary parameter indicative of the resistance between the fifth electrode pair (fifth electrode and ground electrode) and TH_6_1 is a sixth primary threshold value, TH_6_2 is a sixth secondary threshold value TH_6_3 is a sixth tertiary threshold value, and ∇P_4_1 is gradient of P_4_1, ∇P_4_2 is gradient of P_4_2, ∇P_4_3 is gradient of P_4_3, and V is a gradient limit (e.g. 80%). In one or more exemplary embodiments, the sixth primary threshold value TH_6_1 may correspond to an upper resistance threshold value. In one or more exemplary embodiments, TH_6_2 may correspond to an upper resistance threshold value. In one or more exemplary embodiments, TH_6_3 may correspond to an upper resistance threshold value. An upper resistance threshold value may be set to a value which is less than 30 Mega-Ohms, such as 25 Mega-Ohms, such as 20.5 Mega-Ohms, such as 20.4 Mega-Ohms. The sixth operating state may refer to presence of output detected by the fourth parameter data indicating a sudden leak, e.g. a developing leak. In one or more exemplary embodiments, when the time T is below X minutes from the placement of the base plate, where X is between 5 to 60 minutes, and when any of P_1_1, P_2_1, P_3_1 in average over T are below a default threshold value corresponding to an upper resistance threshold value, this indicates that any of the first electrode pair, the second electrode pair, and the third electrode pair is cut (e.g. cut by the user when preparing the base plate for placement around the stoma). In one or more exemplary embodiments, when the time T is below X minutes from the placement of the base plate, where X is between 5 to 60 minutes, and when any of P_4_1, P_4_2, P_4_3 in average over T are below a default threshold value corresponding to an upper resistance threshold value, this indicates an instant leakage, e.g. presence of output on the proximal side.

In one or more exemplary embodiments, any of the first criteria set, the second criteria set, the third criteria set, the fourth criteria set, the default criteria set, the fifth criteria set, the sixth criteria set may be used to define one or more further criteria sets, and thereby to determine one or more operating states.

In one or more exemplary embodiments, different criteria sets may be used to determine the same operating state.

The monitor device comprises a monitor device housing optionally made of a plastic material. The monitor device housing may be an elongate housing having a first end and a second end. The monitor device housing may have a length or maximum extension along a longitudinal axis in the range from 1 cm to 15 cm. The monitor device housing may have a width or maximum extension perpendicular to the longitudinal axis in the range from 0.5 cm to 3 cm. The monitor device housing may be curve-shaped.

The monitor device comprises a first interface. The first interface may be configured as an appliance interface for electrically and/or mechanically connecting the monitor device to the ostomy appliance. Thus, the appliance interface is configured to electrically and/or mechanically couple the monitor device and the ostomy appliance. The first interface may be configured as an accessory device interface for electrically and/or mechanically connecting the monitor device to an accessory device, such as a docking station. The first interface may be configured for coupling to a docking station of the ostomy system, e.g. for charging the monitor device and/or for data transfer between the monitor device and the docking station.

The first interface of the monitor device may comprise a plurality of terminals, such as two, three, four, five, six, seven or more terminals, for forming electrical connections with respective terminals and/or electrodes of the ostomy appliance. One or more terminals of the first interface may be configured for forming electrical connections with an accessory device, e.g. with respective terminals of a docking station. The first interface may comprise a ground terminal. The first interface may comprise a first terminal, a second terminal and optionally a third terminal. The first interface may comprise a fourth terminal and/or a fifth terminal. The first interface optionally comprises a sixth terminal. In one or more exemplary monitor devices, the first interface has M terminals, wherein M is an integer in the range from 4 to 8.

The first interface of the monitor device may comprise a coupling part (may alternatively be denoted a device coupling part or a monitor device coupling part) for forming a mechanical connection, such as a releasable coupling between the monitor device and the base plate. The coupling part and the terminals of the first interface form (at least part of) a first connector of the monitor device.

The monitor device comprises a power unit for powering the monitor device. The power unit may comprise a battery. The power unit may comprise charging circuitry connected to the battery and terminals of the first interface for charging the battery via the first interface, e.g. the first connector. The first interface may comprise separate charging terminal(s) for charging the battery.

The monitor device may comprise a sensor unit with one or more sensor. The sensor unit is connected to the processor for feeding sensor data to the processor. The sensor unit may comprise an accelerometer for sensing acceleration and provision of acceleration data to the processor. The sensor unit may comprise a temperature sensor for provision of temperature data to the processor.

The monitor device comprises a second interface connected to the processor. The second interface may be configured as an accessory interface for connecting, e.g. wirelessly connecting, the monitor device to one or more accessory devices. The second interface may comprise an antenna and a wireless transceiver, e.g. configured for wireless communication at frequencies in the range from 2.4 to 2.5 GHz. The wireless transceiver may be a Bluetooth transceiver, i.e. the wireless transceiver may be configured for wireless communication according to Bluetooth protocol, e.g. Bluetooth Low Energy,

Bluetooth 4.0, Bluetooth 5. The second interface optionally comprises a loudspeaker and/or a haptic feedback element for provision of an audio signal and/or haptic feedback to the user, respectively.

In one or more exemplary ostomy systems, the monitor device forms an integrated part of the ostomy appliance, e.g. the monitor device may form an integrated part of a base plate of the ostomy appliance.

The ostomy system may comprise a docking station forming an accessory device of the ostomy system. The docking station may be configured to electrically and/or mechanically couple the monitor device to the docking station.

The docking station may comprise a docking monitor interface. The docking monitor interface may be configured for electrically and/or mechanically connecting the monitor device to the docking station. The docking monitor interface may be configured for wirelessly connecting the monitor device to the docking station. The docking monitor interface of the docking station may be configured to electrically and/or mechanically couple the docking station and the monitor device.

The docking monitor interface of the docking station may comprise, e.g. as part of a first connector of the docking monitor interface, a coupling part for forming a mechanical connection, such as a releasable coupling between the monitor device and the docking station. The coupling part may be configured to engage with a coupling part of the monitor device for releasably coupling the monitor device to the docking station.

The docking monitor interface of the docking station may comprise, e.g. as part of a first connector of the docking monitor interface, a plurality of terminals, such as two, three, four, five, six, seven or more terminals, for forming electrical connections with respective terminals of the monitor device. The docking monitor interface may comprise a ground terminal. The docking monitor interface may comprise a first terminal and/or a second terminal. The docking station may comprise a third terminal. The docking monitor interface may comprise a fourth terminal and/or a fifth terminal. The docking monitor interface optionally comprises a sixth terminal.

Disclosed is an accessory device for an ostomy system having a monitor device and an ostomy appliance. The ostomy appliance can include a base plate. The accessory device may include a memory, a processor, and a monitor interface coupled to the processor.

The monitor interface may communicate with the monitor device. Additionally or alternatively, the monitor interface may obtain monitor data from the monitor device coupled to the ostomy appliance. The processor may be configured to determine an operating state of the base plate. The operating state of the base plate can be indicative of an operating status of the ostomy appliance. The processor may be further configured to receive a sensor parameter value corresponding to a sensor data parameter from at least one sensor. The at least one sensor may be included in the accessory device. In other words, the accessory device may comprise the at least one sensor. In addition, the processor may determine an actual wear time of the ostomy appliance (e.g. actual wear time of the base plate disclosed herein) based on the operating state and the sensor parameter value. The sensor parameter value may affect the wear time of the ostomy appliance (e.g. wear time of the base plate disclosed herein). Advantageously, the processor may determine the wear time based on a sensor parameter value.

Advantageously, the processor may determine the wear time of the base plate based on a sensor parameter value.

To determine the actual wear time, the processor may obtain a previous wear time. The previous wear time may be indicative of an actual wear time. Advantageously, the processor may obtain a previous wear time for determining an actual wear time.

To determine the actual wear time, the processor may be configured to determine an adjustment to the previous wear time based on the sensor parameter value. Additionally or alternatively, to determine the actual wear time, the processor may be configured to obtain a previous sensor parameter value for the sensor data parameter, compare the previous sensor parameter value to the sensor parameter value, and determine the actual wear time based on the comparison. Advantageously, the processor may determine a more accurate actual wear time by comparing previous sensor parameter values to the sensor parameter values and determining the actual wear time based thereon.

The sensor parameter value may be at least one of: a current sensor parameter value and a future sensor parameter value.

Advantageously, at least one sensor may be included in the accessory device. Additionally, the sensor may include a plurality of sensors and at least one sensor of the plurality of sensors may be a remote sensor. Advantageously, the accessory device may receive data from the remote sensor in embodiments where sensor data of the remote sensor isn't available from a sensor included in the accessory device.

The sensor data parameter may include at least one of: temperature data, humidity data, activity data, stoma data, accelerometer data, image data, sound data, input data, and heart-rate data. In addition, the sensor may include at least one of: an audio sensor, an accelerometer, a gyroscope, a magnetometer, a barometer, a camera, a proximity sensor, a temperature sensor, a heart-rate sensor, and a fingerprint sensor. One or more of these sensor data parameters and sensors may affect the actual wear time. Advantageously, the embodiments disclosed herein contemplate using these sensor data parameters.

Additionally or alternatively, to determine the operating state, the processor may be configured to receive the operating state. By receiving the operating state, the processing load of the processor may be reduced and/or the memory requirements of the memory may be reduced.

Also disclosed is a method of operating an accessory device for an ostomy system. The ostomy system may include a monitor device and an ostomy appliance. The ostomy appliance may include base plate. The method may include determining an operating state of the base plate, receiving a sensor parameter value corresponding to a sensor data parameter from at least one sensor; and determining an actual wear time of the ostomy appliance (e.g. wear time of the base plate disclosed herein) based on the operating state and the sensor parameter value. As stated above, sensor parameter value may affect the wear time of the ostomy appliance (e.g. wear time of the base plate disclosed herein). Advantageously, the method may include determining the wear time based on a sensor parameter value.

For the method, determining the actual wear time may include obtaining a previous wear time. The previous wear time may be indicative of an actual wear time. Advantageously, the method may include obtaining a previous wear time for determining an actual wear time. In addition, determining the actual wear time may include determining an adjustment to the previous wear time based on the sensor parameter value.

For the method, determining the actual wear time may include obtaining a previous sensor parameter value for the sensor data parameter, comparing the previous sensor parameter value to the sensor parameter value, and determining the actual wear time based on the comparison. Advantageously, the method may determine a more accurate actual wear time by comparing previous sensor parameter values to the sensor parameter values and determining the actual wear time based thereon.

For the method, the sensor parameter value may be at least one of: a current sensor parameter value and a future sensor parameter value. Advantageously, the embodiments included herein contemplate using anticipated future sensor parameter values to more accurately determine actual wear time.

FIG. 1 illustrates an exemplary ostomy system. The ostomy system 1 comprises an ostomy appliance 2 including a base plate 4 and an ostomy pouch (not shown). Further, the ostomy system 1 comprises a monitor device 6 and an accessory device 8 (mobile telephone). The base plate 4 and the monitor device 6 are in a coupled state, and the monitor device 6 is connectable to the base plate 4 via respective first connectors of the monitor device 6 and base plate 4. The monitor device 6 is configured for wireless communication with the accessory device 8. Optionally, the accessory device 8 is configured to communicate with a server device 10 of the ostomy system 1, e.g. via network 12. The server device 10 may be operated and/or controlled by the ostomy appliance manufacturer and/or a service centre. Ostomy data or parameter data based on the ostomy data are obtained from electrodes/sensors of the ostomy appliance 2 with the monitor device 6. The monitor device 6 processes the ostomy data and/or parameter data based on the ostomy data to determine monitor data that are transmitted to the accessory device 8. The monitor data may include sensor data of the monitor device. In the illustrated ostomy system, the accessory device 8 is a mobile phone or smartphone, however the accessory device 8 may be embodied as another handheld device, such as a tablet device, or a wearable, such as a watch or other wrist-worn electronic device. Accordingly, the monitor device 6 is configured to determine and transmit monitor data to the accessory device 8. The base plate 4 comprises a coupling member 14 in the form of a coupling ring 16 for coupling an ostomy pouch (not shown) to the base plate (two-part ostomy appliance). The base plate 4 has a stomal opening 18 with a stoma center point 19. The size and/or shape of the stomal opening 18 is typically adjusted by the user or nurse before application of the ostomy appliance to accommodate the user's stoma.

The ostomy system 1 optionally comprises a docking station 20 forming an accessory device of the ostomy system 1. The docking station comprises 20 comprises a docking monitor interface including a first connector 22 configured for electrically and/or mechanically connecting the monitor device 6 to the docking station 20. The docking monitor interface may be configured for wirelessly connecting the monitor device to the docking station. The docking station 20 comprises a user interface 24 for receiving user input and/or providing feedback to the user on the operational state of the docking station 20. The user interface 24 may comprise a touch-screen. The user interface 24 may comprise one or more physical buttons and/or one or more visual indicators, such as light emitting diodes.

FIG. 2 is a schematic block diagram of an exemplary monitor device. The monitor device 6 comprises a monitor device housing 100, a processor 101, and one or more interfaces, the one or more interfaces including a first interface 102 (appliance interface) and a second interface 104 (accessory interface). The monitor device 6 comprises a memory 106 for storing ostomy data and/or parameter data based on the ostomy data. The memory 106 is connected to the processor 101 and/or the first interface 102.

The first interface 102 is configured as an appliance interface for electrically and/or mechanically connecting the monitor device 6 to the ostomy appliance, e.g. ostomy appliance 2. The first interface 102 comprises a plurality of terminals for forming electrical connections with respective terminals of the ostomy appliance 2 (base plate 4). The first interface 102 comprises a ground terminal 108, a first terminal 110, a second terminal 112 and a third terminal 114. The first interface 102 optionally comprises a fourth terminal 116 and a fifth terminal 118. The first interface 102 of the monitor device 6 comprises a coupling part 120 for forming a mechanical connection, such as a releasable coupling between the monitor device and the base plate. The coupling part 120 and the terminals 108, 110, 112, 114, 116, and 118 of the first interface 102 form (at least part of) a first connector of the monitor device 6.

The monitor device 6 optionally comprises a sensor unit 140 connected to the processor 101 for provision of sensor data 142 to the processor 101. The sensor unit 140 comprises a first sensor 144 being a temperature and humidity sensor for feeding temperature and humidity data as sensor data 142 to the processor 101. Further, the sensor unit 140 comprises a second sensor 146 being an accelerometer for feeding acceleration data as sensor data 142 to the processor 101. The processor 101 receives and stores sensor data 142 comprising temperature data, humidity data, and acceleration data, in the memory 106 and/or transmits the sensor data as part of monitor data via second interface 104.

The monitor device 100 is configured to obtain ostomy data from the base plate coupled to the first interface 102. The ostomy data may be stored in the memory 106 and/or processed in the processor 101 in order to obtain parameter data based on the ostomy data.

The monitor device 6 comprises a power unit 121 for powering the monitor device and active components thereof, i.e. the power unit 121 is connected to the processor 101, the first interface 102, the second interface 104, and memory 106. The power unit comprises a battery and charging circuitry. The charging circuitry is connected to the battery and terminals of the first interface 102 for charging the battery via terminals of the first interface, e.g. terminals of the first connector.

The second interface 104 of monitor device is configured as an accessory interface for connecting the monitor device 6 to one or more accessory devices such as accessory device 8. The second interface 104 comprises an antenna 122 and a wireless transceiver 124 configured for wireless communication with accessory device(s). Optionally, the second interface 104 comprises a loudspeaker 126 and/or a haptic feedback element 128 for provision of respective audio signal and/or haptic feedback to the user.

The monitor device 6 comprises a sensor unit 140 connected to the processor 101. The sensor unit 140 comprises a temperature sensor for feeding temperature data to the processor and a G-sensor or accelerometer for feeding acceleration data to the processor 101.

The processor 101 is configured to apply a processing scheme, and the first interface 102 is configured for collecting ostomy data from the base plate coupled to the first interface, the ostomy data comprising first ostomy data from a first electrode pair of the base plate, second ostomy data from a second electrode pair of the base plate, and third ostomy data from a third electrode pair of the base plate. The ostomy data may be stored in the memory 106 and/or processed in the processor 101 in order to obtain parameter data.

The parameter data may be stored in the memory 106. The processor 101 is configured to apply a processing scheme, wherein to apply a processing scheme comprises obtain first parameter data based on the first ostomy data; obtain second parameter data based on the second ostomy data; obtain third parameter data based on the third ostomy data. In other words, the processor 101 is configured to obtain first, second and third parameter data based on respective first, second and third ostomy data. To apply a processing scheme comprises to determine an operating state of the base plate of the ostomy appliance based on one or more, e.g. all, of the first parameter data, the second parameter data and the third parameter data, wherein the operating state is indicative of a degree of radial erosion of the base plate and/or acute leakage risk for the ostomy appliance. The monitor device 6 is configured to, in accordance with a determination that the operating state is a first operating state, transmit a first monitor signal comprising monitor data indicative of the first operating state of the base plate via the second interface; and in accordance with a determination that the operating state is a second operating state, transmit a second monitor signal comprising monitor data indicative of the second operating state of the base plate via the second interface.

FIG. 3 illustrates an exploded view of an exemplary base plate of an ostomy appliance. The base plate 4 comprises a first adhesive layer 200 with a stomal opening 18A. During use, a proximal surface of the first adhesive layer 200 adheres to the user's skin in the peristomal area and/or to additional seals, such as sealing paste, sealing tape and/or sealing ring. The base plate 4 optionally comprises a second adhesive layer 202, also with a stomal opening 18B. The base plate 4 comprises a plurality of electrodes arranged in an electrode assembly 204. The electrode assembly 204 is arranged between the first adhesive layer 200 and the second adhesive layer 202. The electrode assembly 204 comprises a support layer with stomal opening 18C and electrodes formed on a proximal surface of the support layer. The base plate 4 comprises a release liner 206 that is peeled off by the user prior to applying the base plate 4 on the skin. The base plate 4 comprises a top layer 208 with a stomal opening 18D and a coupling ring 209 for coupling an ostomy pouch to the base plate 4. The top layer 208 is a protective layer protecting the second adhesive layer 202 from external strains and stress during use.

The base plate 4 comprises a monitor interface. The monitor interface is configured for electrically and/or mechanically connecting the ostomy appliance (base plate 4) to the monitor device. The monitor interface of the base plate comprises a coupling part 210 for forming a mechanical connection, such as a releasable coupling between the monitor device and the base plate. The coupling part 210 is configured to engage with a coupling part of the monitor device for releasably coupling the monitor device to the base plate 4. Further, the monitor interface of the base plate 4 comprises a plurality of terminal elements respectively forming a plurality of terminals 212 for forming electrical connections with respective terminals of the monitor device. The coupling part 210 and the terminals 212 form a first connector 211 of the base plate 4. The base plate 4 comprises a first intermediate element 213 on the distal side of the electrode assembly. The first intermediate element 213 is arranged between the terminal elements forming terminals 212 and the first adhesive layer (not shown). The first intermediate element 213 covers the terminal elements forming terminals 212 of the base plate 4 when seen in the axial direction and protects the first adhesive layer from mechanical stress from the terminal elements of the base plate.

FIG. 4 illustrates an exploded view of an exemplary electrode assembly 204 of a base plate. The electrode assembly 204 has a distal side 204A and a proximal side 204B. The electrode assembly 204 comprises a support layer 214 with proximal surface 214B and electrodes 216 arranged on the proximal side of the support layer 214 and including a ground electrode, a first electrode, a second electrode, a third electrode, a fourth electrode, and a fifth electrode, wherein each electrode has a respective connection part 217 for connecting the electrodes 216 to respective terminal elements of the monitor interface. The electrodes 216 are positioned and/or formed, on a proximal side 214B of the support layer 214. Further, electrode assembly 204 comprises a masking element 218 with proximal surface 218B and configured to insulate electrode parts of electrodes 216 from the first adhesive layer of the base plate. The masking element 218 covers or overlap with parts of the electrodes 216 when seen in the axial direction.

FIG. 5 is a proximal view of proximal surfaces of base plate parts of the base plate without the first adhesive layer and the release liner. The base plate 4 comprises a first intermediate element 213 on the distal side of the electrode assembly, i.e. between the electrode assembly 204 and the first adhesive layer (not shown). The first intermediate element 213 covers the terminal elements of the base plate 4 when seen in the axial direction and protects the first adhesive layer from mechanical stress from the terminal elements of the base plate.

FIG. 6 is a distal view of an exemplary electrode configuration 220 of electrodes 216 of the electrode assembly 204. The electrode configuration 220/electrode assembly 204 comprises a ground electrode 222, a first electrode 224, a second electrode 226, a third electrode 228, a fourth electrode 230, and a fifth electrode 232. The ground electrode 222 comprises a ground connection part 222A and the first electrode 224 comprises a first connection part 224A. The second electrode 226 comprises a second connection part 226A and the third electrode 228 comprises a third connection part 228A. The fourth electrode 230 comprises a fourth connection part 230A and the fifth electrode 232 comprise a fifth connection part 232A.

The fourth electrode 230 comprises fourth sensing parts 230B. The fifth electrode 232 comprises fifth sensing parts 232B.

The ground electrode 222 comprises a first electrode part 234 for forming a ground or reference for the first electrode 224. The ground electrode 222 comprises a second electrode part 236 for forming a ground or reference for the second electrode 226. The ground electrode 222 comprises a third electrode part 238 for forming a ground or reference for the third electrode 228. The masking element 218 is arranged proximal to the electrodes 222, 224, 226, 228 covering and insulating parts of the electrodes from the first adhesive and forming respective conductor parts of the electrodes 222, 224, 226, 228. The parts of the electrodes 222, 224, 226, 228 not covered by the masking element 219 contacts the first adhesive layer and form sensing parts 224B, 226B, 228B of electrodes 224, 226, 228, respectively. Further, the electrode parts 234, 236, 238 form sensing parts of the ground electrode 222.

The first sensing part 224B extends circularly at least 330 degrees around the stomal opening at a first radial distance R1 from the center point 19. The first radial distance R1 may be around 14 mm. In one or more embodiments, the first radial distance R1 may be around 13 mm, such as 12.5 mm. The first electrode part 234 is arranged on the inside of the first sensing part (i.e. closer to the center point) and extends circularly at least 330 degrees around the stomal opening at a first ground distance RG1 from the first sensing part (radially from the center point). The first ground distance RG1 between sensing part of first electrode and first electrode part is about 1 mm.

The second sensing part 226B extends circularly at least 330 degrees around the stomal opening at a second radial distance R2 from the center point 19. The second radial distance R2 may be 18 mm. In one or more embodiments, the second radial distance R2 may be 17 mm. The second electrode part 236 is arranged on the inside of the second sensing part 226B (i.e. closer to the center point) and extends circularly at least 330 degrees around the stomal opening at a second ground distance RG2 from the second sensing part 226B (radially from the center point). The second ground distance RG2 between sensing part of second electrode and second electrode part is about 1 mm.

The third sensing part 228B extends circularly at least 330 degrees around the stomal opening at a third radial distance R3 from the center point 19. The third radial distance R3 is about 26 mm. In one or more embodiments, the third radial distance R3 is 21 mm. The third electrode part 238 is arranged on the inside of the third sensing part 228B (i.e. closer to the center point) and extends circularly at least 330 degrees around the stomal opening at a third ground distance RG3 from the third sensing part 228B (radially from the center point). The third ground distance RG3 between sensing part of third electrode and third electrode part is about 1 mm.

The ground electrode 222 comprises a fourth electrode part 240 for forming a ground or reference for the fourth electrode 230 and the fifth electrode 232. The fourth electrode part 240 of the ground electrode 222 extends at least 300 degrees around the stomal opening and comprises ground sensing parts 222B. The fourth sensing parts 230B, fifth sensing parts 232B, and ground sensing parts of the fourth electrode part 240 are circularly distributed around the center point 19 at a leakage radius from the center point (such as a leakage radius R5 which may be around 32 mmm from the center point). The fourth sensing parts 230B, fifth sensing parts 232B, and ground sensing parts of the fourth electrode part may have a radial extension larger than 1.0 mm, such as in the range from 1.5 mm to 3.0 mm, e.g. about 2.0 mm. The fourth sensing parts 230B, fifth sensing parts 232B, and ground sensing parts of the fourth electrode part 240 may have a circumferential extension (perpendicular to the radial extension) larger than 1.0 mm, such as in the range from 2.5 mm to 5.0 mm, e.g. about 3.5 mm.

FIG. 7 is a distal view of an exemplary masking element. The masking element 218 optionally has a plurality of terminal openings including six terminal openings. The plurality of terminal openings comprises a ground terminal opening 242, a first terminal opening 244, a second terminal opening 246, a third terminal opening 248, a fourth terminal opening 250, and a fifth terminal opening 252. The terminal openings 242, 244, 246, 248, 250, 252 of the masking element 218 are configured to overlap and/or be aligned with respective connection parts 222A, 224A, 226A, 228A, 230A, 232A of the electrodes of the electrode assembly.

The masking element 218 has a plurality of sensor point openings. The sensor point openings comprise primary sensor point openings shown within dotted line 254, each primary sensor point opening configured to overlap a part of the ground electrode 222 and/or a part of the fourth electrode 230. The primary sensor point openings 254 comprise, in the illustrated exemplary masking element, five primary first sensor point openings 254A each configured to overlap a part of the ground electrode 222. The primary sensor point openings 254 comprise, in the illustrated exemplary masking element, four primary second sensor point openings 254B each configured to overlap a part of the fourth electrode 230. The sensor point openings comprise secondary sensor point openings shown within dotted line 256, each second sensor point opening configured to overlap a part of the fourth electrode 230 and/or a part of the fifth electrode 232. The secondary sensor point openings 256 comprise, in the illustrated exemplary masking element, five secondary first sensor point openings 256A each configured to overlap a part of the fifth electrode 232. The secondary sensor point openings 256 comprise, in the illustrated exemplary masking element, four secondary second sensor point openings 256B each configured to overlap a part of the fourth electrode 230. The sensor point openings comprise tertiary sensor point openings shown within dotted line 258, each tertiary sensor opening configured to overlap a part of the fifth electrode 232 and/or a part of the ground electrode 222. The tertiary sensor point openings 258 comprise, in the illustrated exemplary masking element, five tertiary first sensor point openings 258A each configured to overlap a part of the fifth electrode 232. The tertiary sensor point openings 258 comprise, in the illustrated exemplary masking element, four tertiary second sensor point openings 258B each configured to overlap a part of the ground electrode 222.

FIG. 8 is a distal view of an exemplary first adhesive layer. The first adhesive layer 200 has a plurality of sensor point openings. The sensor point openings of the first adhesive layer comprise primary sensor point openings shown within dotted line 260, each primary sensor point opening configured to overlap a part of the ground electrode 222 and/or a part of the fourth electrode 230 of the electrode assembly. The primary sensor point openings 260A, 260B comprise, in the illustrated exemplary first adhesive layer, five primary first sensor point openings 260A each configured to overlap a part of the ground electrode 222. The primary sensor point openings 260A, 260B comprise, in the illustrated exemplary first adhesive layer, four primary second sensor point openings 260B each configured to overlap a part of the fourth electrode 230. The sensor point openings of the first adhesive layer comprise secondary sensor point openings shown within dotted line 262, each second sensor point opening configured to overlap a part of the fourth electrode 230 and/or a part of the fifth electrode 232 of the electrode assembly. The secondary sensor point openings 262A, 262B comprise, in the illustrated exemplary first adhesive layer, five secondary first sensor point openings 262A each configured to overlap a part of the fifth electrode 232. The secondary sensor point openings 262A, 262B comprise, in the illustrated exemplary first adhesive layer, four secondary second sensor point openings 262B each configured to overlap a part of the fourth electrode 230. The sensor point openings of the first adhesive layer comprise tertiary sensor point openings shown within dotted line 264, each tertiary sensor opening configured to overlap a part of the fifth electrode 232 and/or a part of the ground electrode 222 of the electrode assembly. The tertiary sensor point openings 264A, 264B comprise, in the illustrated exemplary first adhesive layer, five tertiary first sensor point openings 264A each configured to overlap a part of the fifth electrode 232. The tertiary sensor point openings 264A, 264B comprise, in the illustrated exemplary first adhesive layer, four tertiary second sensor point openings 264B each configured to overlap a part of the ground electrode 222. FIG. 9 is a proximal view of the first adhesive layer of FIG. 8.

FIG. 10 is a more detailed distal view of a part of the base plate 4. Monitor interface of the base plate comprises the first connector 211. The first connector 211 comprises coupling part 210 configured to releasably couple the monitor device to the base plate and thus forming a releasable coupling. The first connector 211/monitor interface comprises a plurality of terminals formed by respective terminal elements for forming respective electrical connections with respective terminals of the monitor device.

The plurality of terminals of the first connector 211/monitor interface comprises a ground terminal element 282 forming a ground terminal 282A, a first terminal element 284 forming a first terminal 284, a second terminal element 286 forming a second terminal 286A, and optionally a third terminal element 288 forming a third terminal 288A. The monitor interface optionally comprises a fourth terminal element 290 forming a fourth terminal 290A and/or a fifth terminal element 292 forming a fifth terminal 290. The terminal elements 282, 284, 286, 288, 290, 292 contact respective connection parts 222A, 224A, 226A, 228A, 230 a, 232A of electrodes 222, 224, 226, 228, 230, 232.

FIG. 11 is an illustrative block diagram representing an exemplary accessory device 8 configured to determine a wear time of an ostomy appliance 2 based on sensor data. As discussed in more detail below, sensor data associated with a user of an ostomy appliance 2 may affect the wear time of the ostomy appliance 2 (e.g. the wear time of the base plate 4 disclosed herein). That is, sensor data associated with the user, the user's activities, and/or the user's environment may affect the wear time. As such, the embodiments discussed herein relate to determining a wear time based on sensor data associated with the user, the user's activities, and/or the user's environment.

As illustrated in FIG. 11, the accessory device 8 may be in communication with a server 302 and/or a database 304 via a wired or non-wired connection 306. The server 302 and/or the database 304 may facilitate the determination of a previous wear time and/or an actual wear time as discussed below. Additionally or alternatively, the server 302 and/or the database 304 may include a seconds analytics application (e.g., the operating state module 318, the sensor data module, the previous wear time module 322, and/or the actual wear time module 324, see below for description of these modules). Additionally, the accessory device 8 may be in communication with a transmitter 308 via one or more signals 310, which can be used to provide sensor data to the accessory device 8, as explained below.

The accessory device 8 includes a processor 314 and a memory 316. The processor 314 and the memory 316 may be operatively and communicably coupled via a bus 312. The processor 314 can be a central processing unit (CPU), but other suitable microprocessors are also contemplated. The processer 314 may be configured to store information in the memory 316 and/or access information from the memory 316. The processer 314 may also execute instructions and perform desired tasks as specified by computer-executable instructions stored in the memory 316.

The memory 316 includes computer-readable media in the form of volatile and/or nonvolatile memory and may be removable, nonremovable, or a combination thereof. In embodiments, the memory 316 stores computer-executable instructions for causing the processor 314 to implement aspects of the embodiments discussed herein. For example, one or more modules may be loaded from the memory 316 onto the processor 314 for determining the wear time of an ostomy appliance 2 as described herein (e.g. wear time of the base plate 4 described herein). Exemplary modules include an operating state module 318, a sensor data module 320, a previous wear time module 322, and/or an actual wear time module 324 used for the purposes discussed below.

The accessory device 8 may also include a monitor interface 326, a receiver 328, a sensor 330, an input device 332, and a display 334 all of which may be operatively and communicably coupled to the processor 314 via a bus 312.

The monitor interface 326 may be configured to communicate with one or more devices of the ostomy system 1. The one or more devices include, for example, the monitor device 6 disclosed herein, and/or the ostomy appliance 2. In at least one embodiment, the monitor interface 326 is configured to obtain monitor data from the monitor device 6. The monitor data may be indicative of an operating state 336 of the ostomy appliance 2 (e.g., operating state 336 of the base plate 4).

As discussed above, the operating state 336 may include a first operating state indicative of the base plate 4 corresponding to a situation wherein the first adhesive layer 200 has experienced a first degree of radial erosion, a second operating state indicative of the base plate 4 corresponding to a situation wherein the first adhesive layer 200 has experienced a second degree of radial erosion, a third operating state indicative of the base plate 4 corresponding to a situation wherein the first adhesive layer 200 has experienced a third degree of radial erosion. Further, the operating state 336 can include a fourth operating state indicative of the base plate 4 corresponding to a situation wherein a sensor attached to the base plate 4 detects a presence of fluid, such as output, between the skin of the user and a distal surface of first adhesive layer 206, indicating that a high risk of leakage from the ostomy appliance 2.

Further, the operating state 336 can include a fifth operating state indicative of a degree of attrition of the ostomy bag based on an expiration date of the ostomy bag. The fifth operating state can also be indicative of the ostomy bag corresponding to a situation wherein the ostomy bag has expired for further use. Similarly, the operating state 336 can include a sixth operating state indicative of a degree of attrition of the base plate 4 based on an expiration date of the base plate 4.

In some embodiments, the monitor device 6 may calculate the operating state 336 and send the operating state 336 to the monitor interface 326 of the accessory device 8. Additionally or alternatively, the monitor interface 326 may receive data from the monitor device 6 and the processor 314 may calculate, using the operating state module 318, the operating state 336 of the ostomy appliance 2 (e.g., of the base plate) based on the received data from the monitor device 6. Additionally or alternatively, a user may input the operating state 336 via an input device 332. The processor 314 receiving the operating state 336 from the monitor device 6, calculating the operating state 336 based on data received from the monitor device 6, and being input into the accessory device 8 all may be referred to herein as the processor 314 determining the operating state 336 of the ostomy appliance 6. The processor 314 may save the operating state 336 in the memory 316 and/or use the operating state 336 to determine the wear time of the ostomy appliance 2, more specifically of the base plate 4.

Wear time may indicate the length of time a user is able to wear an ostomy appliance 2 before there is an acute leakage risk for the ostomy appliance 2. For example, the wear time may indicate the length of time a user is able to wear the ostomy appliance 2 before the base plate 4 is in a fourth operating state. Some ostomy users, however, may want to know the length of time a user is able to wear the ostomy appliance 2 before there is an acute leakage risk. As such, the wear time may be configurable by a user. That is, the user may configure the wear time to indicate the length of time a user is able to wear the ostomy appliance 2 before the base plate 4 is in a first operating state, a second operating state, or a third operating state. Additionally or alternatively, a user may define an operating state. In these embodiments, the wear time may indicate the length of time a user is able to wear the ostomy appliance 2 before the ostomy appliance 2 is in the user-defined operating state.

For the example embodiments discussed below, wear time may indicate the time remaining until the base plate 4 reaches the fourth operating state. However, the example embodiments also apply for the wear time being defined as the time remaining until the ostomy appliance 2 is in another operating state, whether it is a user-defined operating state or a predefined operating state (e.g., first operating state, the second operating state, the third operating state, fifth operating state, and/or sixth operating state).

As stated above, the accessory device 8 of an ostomy system 1 may include one or more sensors 330. For example, the one or more sensors 330 may include, but are not limited to, an audio sensor, an accelerometer, a gyroscope, a magnetometer, a barometer, a camera, a proximity sensor, a temperature sensor, a heart-rate sensor, and a fingerprint sensor. The foregoing types of sensors 330 may reside on board the accessory device 8. For example, the accessory device 8 may be a phone, a tablet or a wearable that includes a thermometer that can sense the temperature. As a further example, an accelerometer may sense a movement type. That is, the user may be sleeping or otherwise relatively still, which the accelerometer may sense. Alternatively, the accelerometer may sense that the user is walking, jogging, or exercising vigorously. Alternatively or additionally, one or more sensors 330 that are accelerometers or barometers can be used to sense whether the user is climbing, such as while hiking. Additionally, a barometer can be used to sense atmospheric pressure that is indicative of weather conditions. Any or all of these sensors 330 may be used to determine the wear time of the ostomy appliance 2 (e.g. specifically the wear time of the base plate 4 disclosed herein).

The sensors 330 may further include a camera associated with the accessory device 8, wherein the camera can be used to provide an image of the user's stoma. The image may be processed by processor 314 and/or an application on the server 302 for assessing whether there is any wear time adjustment necessary. For example, if processing of an image of the user's stoma results in a determination of inflammation, such determination may modify the value determined for the wear time of the base plate 4.

In addition to using on-board sensors 330 residing on, plugged into, or wired to the accessory device 8, one or more transmitters(s) 308 can optionally be used to further provide additional sensor data via the receiver 328 to augment the sensor data directly collected by any operating sensors 330 of the accessory device 8. For example, a user may have a wearable, such as a watch or a ring (not shown), that collects activity data via a remote sensor 331 (here, “remote sensor” means not residing on, plugged into, or wired to the accessory device 8), such as by using an accelerometer, wherein such sensor data can be transmitted to the accessory device 8 and used by the accessory device 8 to determine a wear time. Alternatively, the monitoring device 6 may include a remote sensor 331, such as an audio sensor that can sense peristaltic contractions of the user, and transmit such sensor data to the accessory device 8 for use in determining a wear time. Additionally or alternatively, a wearable may include one or more remote sensors 331 to monitor heart function of the user, such as the heart rate, heart rhythm, and/or hear sounds of the user, and wherein such remote sensors 331 convey sensor data to the accessory device 8 using a transmitter 308.

Other sensors, whether on-board sensors 330 resident on the accessory device 8 or remote sensors 331 spaced apart from the accessory device 8 can further provide relevant sensor data that can be used to determine a wear time. For example, humidity can be measured by a remote sensor 331 in the form of a hygrometer residing within the residence of the user, and thereafter the sensor data can be conveyed to the accessory device 8 using an associated transmitter 308 and the receiver 328 of the accessory device 8. Alternatively or additionally, if a user is outdoors, other relevant data can be conveyed to the accessory device 8. By way of example, if a user is traveling, such as by an automobile, associated relevant sensor data can be measured and conveyed to the user's accessory device 8 so that a wear time can be determined. Accordingly, one or more embodiments include the use of at least one sensor 330 residing on board the accessory device 8, or at least one remote sensor 331 spaced apart from the accessory device 8 and transmitting sensor data to the accessory device 8 via a transmitter 308 and received by a receiver 328 of the accessory device 8, or a combination of sensor data gathered by at least one sensor 330 on board the accessory device 8 and by a remote sensor 331 spaced apart from and transmitting sensor data to the accessory device 8.

Exemplary sensor data parameters may include, but are not limited to: temperature, barometric pressure, user heart rate, user activity level, as well as other parameters being monitored. One or more of these sensor parameters may be used to determine wear time. As an example, assume a sensor parameter is humidity. And, the current value of the sensor parameter (i.e., humidity) for accessory device is 50%. Based on a current humidity value of 50% and a current operating state 336, the processor 314 may determine the actual wear time is 10 units by, for example, querying a lookup table.

Referring again to FIG. 11, in at least one embodiment, the processor 314 uses the operating state module 318 to obtain an operating state from the monitor device 6 and stores the operating state in the operating state 336 of the memory 302. The processor 314 also is configured to receive sensor data using the sensor module 320 and store the sensor data in the sensor data parameters 338 of the memory 302. The processor 314 is further configured to utilize the actual wear time module 324 to determine a wear time based on the combination of both the operating state 336 and the sensor data parameters 338. Accordingly, for at least one operating state, if a certain sensor reading is obtained, the processor 314 determines a wear time.

In at least one embodiment, the wear time may be determined by the processor 314 by accessing a lookup table, such as a wear time lookup table 346 residing on a database 304 and/or memory 316 of the accessory device 8. FIG. 12 illustrates an example of a portion of a wear time lookup table 346, wherein for a given operating state 336, the sensor data parameters 338 are used to determine an actual wear time 344. Accordingly, the wear time lookup table 346 includes a number of sensor data parameters 338 (i.e., sensor data parameter X₁ 338A, sensor data parameter X₂ 338B, . . . , and sensor data parameter X_(n) 338C). Associated with each sensor data parameter 338A, 338B, 338C are wear time values 344. Accordingly, if the processor 314 obtains a sensor parameter value 338A1 for sensor data parameter X₁ 338A, then the processor 314 can determine a wear time value 344A1. Likewise, if the processor 314 obtains a sensor parameter value 338B1 for sensor data parameter X₂ 338B, then the processor 314 can determine a wear time value 344B1. Similarly, if the processor 314 obtains a sensor parameter value 338C1 for sensor data parameter X_(n) 338C, then the processor 314 can determine a wear time value 344C1. Therefore, actual wear times 344 (e.g., wear time values 344A1, 344B1, 344C1) can be obtained if one or more sensor values are known.

In addition to the wear time lookup table 346, the processor 314 may access a previous wear time lookup table 354 that includes previous sensor parameters values 356 of sensor data parameters 338A, 338B, 338C associated with the previous wear times 358, as shown in FIG. 13. That is, the previous wear time 358A may be associated with a previous sensor parameter value 356A for sensor data parameter X₁ 338A, a previous sensor parameter value 356B for sensor data parameter X₂ 338B, and a previous sensor parameter value 356C for sensor data parameter X_(n) 338C. Similarly, a different previous wear time 358B may be associated with a previous sensor parameter value 356D for sensor data parameter X₁ 338A, a previous sensor parameter value 356E for sensor data parameter X₂ 338B, and a previous sensor parameter value 356F for sensor data parameter X_(n) 338C.

Referring back to the example discussed above, if a processor 314 obtains sensor data from one or more sensors 330 associated with an accessory device 8 and an ostomy appliance 2, then the processor 314 may determine the actual wear time 344 of the ostomy appliance 2 by: comparing the sensor parameter values 338A1-338A3 with the previous sensor parameter value 356A and/or the previous sensor parameter value 356D, comparing the sensor parameter values 338B1-338B3 with the previous sensor parameter value 356B and/or the previous sensor parameter value 356E, and/or comparing the sensor parameter values 338C1-338C3 with the previous sensor parameter value 356C and/or the previous sensor parameter value 356F. Exemplary calculations for determining the actual wear time based on a comparison of sensor parameter values 338 and previous sensor parameter values 356 are discussed below in relation to FIGS. 14-17.

While the previous wear time lookup table 354 is depicted as a separate lookup table than the wear time lookup table 346, the previous wear time lookup table 354 may be part of the same lookup table as the wear time lookup table 346. In embodiments, the previous wear times 358 and/or the previous sensor parameter values 356 may be saved on memory 316 and/or on a database (e.g., database 304) external to the memory 316.

Referring back to FIG. 11, the input device 332 of the accessory device 8 may be configured to receive input from a user. The input device 332 can be a keyboard, an interactive screen, a pointing device, and the like for inputting data. The input can include an activity of the user (e.g., the user can input an exercise or resting activity into the accessory device), a previous wear time 358, an operating state 336 and/or a definition of a wear time.

The display 334 of the accessory device 8 can be a touch screen or a monitor, or the like. The display 334 may display the accessory device's 8 sensors 330, an operating state 336, sensor data 338, a previous wear time 358, and/or an actual wear time 344, as discussed below.

As stated above, the processor 314 can receive and load the previous wear time module 322 and the actual wear time module 324 to calculate an actual wear time 344. Descriptions of these modules 322, 324 are provided below in the paragraphs related to FIGS. 14-17, e.g. respective user interface object representative thereof.

Referring to FIG. 14, a graph 360 illustrating a previous wear time 358A as a function of time is depicted. As described above in relation to FIG. 13, previous sensor parameter values 356A, 356B, 356C are associated with the previous wear time 358A. In addition to the previous wear time 358A, an actual wear time 344D as a function of time is depicted. The actual wear time 344D is associated with one or more sensor parameter values of sensor data parameters 338. For example, the actual wear time 344D may be associated with sensor parameter values 357A, 357B, 357C sensed by the sensors 330.

In embodiments, the sensor parameter values 357A, 357B, 357C for the actual wear time 344D may be similar but not the same as previous sensor parameter values 356A, 356B, 356C. To determine the actual wear time 344D, the processor, using the actual wear time module 324, compares the previous sensor parameter values 356A, 356B, 356C to the sensor parameter values 357A, 357B, 357C. Based on the comparison, the processor 314 can determine the actual wear time 344D.

In this example, the processor 314 decreases the actual wear time 344D to 5 units of wear time, a decrease of 1 unit of wear time in comparison to the previous wear time 358A. The decrease may result from one or more of the sensor parameter values 357A, 357B, 357C being less favourable to wear time than the previous sensor parameter values 356A, 356B, 356C. For example, one of the sensor parameter values 357A, 357B, 357C may correspond to humidity. And, the sensor parameter value 357A, 357B, 357C corresponding to humidity may be more humid than the previous sensor parameter values 356A, 356B, 356C corresponding to humidity, which may have an adverse effect on wear time. As a result, the actual wear time 344D is one unit of time less than the previous wear time 358A.

As another example, another actual wear time 344E is depicted. In this example, the actual wear time 344E may be associated with sensor parameter values 357D, 357E, 357F, which may be different than previous sensor parameter values 356A, 356B, 356C. Similar to above, the processor 314, using the actual wear time module 324, determines the actual wear time 344E of an ostomy appliance 2 associated with an accessory device 8 sensing sensor parameter values 357D, 357E, 357F, by comparing the previous sensor parameter values 356A, 356B, 356C with the sensor parameter values 357D, 357E, 357F. Based on the comparison, the actual wear time 344E can be determined. In this example, the actual wear time 3444E is longer than the previous wear time 358A. However, the increase isn't linear. In this example, at time point 362, the actual wear time 344E is increased even more than the initial increase. This may result from an anticipation that the user of the ostomy appliance 2 will change from having sensor parameter values 357D, 357E, 357F, which is favourable to extending the wear time of the ostomy appliance 2 (e.g. wear time of the base plate 4 disclosed herein) over the previous wear time 358A, to future sensor parameter values that are even more favourable to extending the wear time of the ostomy appliance 2 (e.g. wear time of the base plate 4 disclosed herein) than the first location by, for example, changing location and/or activity type. As such, the processor 314 determines the actual wear time to be 8 units of time, 2 units of time greater than the previous wear time 358A.

While the embodiments are discussed in relation to determining an actual wear time 344 from the previous wear time 358A, the processor 314 may determine the actual wear time 344 from the previous wear time 358B (or another previous wear time 358) in situations where the previous wear time 358B (or another previous wear time 358) is better suited for determining the actual wear time 344. For example, sensor data parameters may have a non-linear effect on wear time. As such, the processor 314 may determine the previous sensor parameters values 356 (e.g., previous sensor parameter values 356D, 356E, 356F) that are closest to the sensor parameter values 357 and determine an actual wear time 344 based on the previous wear time 358 associated with those previous sensor parameter values 356. This may reduce any non-linear effects of the location parameters on wear times.

To determine potential future sensor parameter values (e.g., the sensor parameter values depicted after time point 362), the processor 314 may query activity input data 364 input into the input device 332 and potentially saved to, e.g., memory 316, as shown in FIG. 15. That is, FIG. 15 shows the activity input data 364 of future activities, namely, activity A 366A, activity B 366B, and activity N 366C, collectively designated 366. In FIG. 15, each activity 366A, 366B, 366N includes the type of activity to be performed. The sensor data module 320 may receive and/or access the activity input data 364 to determine the future sensor parameter values associated with the type of activity by, for example, querying a lookup table (e.g., the wear time lookup table 346 and/or the previous wear time lookup table 354). The processor 314, using the actual wear time module 324, can then use the respective future sensor parameter values associated with the activities for determining the actual wear time 344 (e.g., the actual wear time 344E).

As described above in relation to FIG. 14, the actual wear time 344 may be determined from a previous wear time 358. To do so, the processor 314, using the actual wear time module 324, may determine a best fit equation based on previous wear times 358 and previous sensor parameters values 356 associated with those previous wear times 358.

FIG. 16 depicts a graph 368 of a plurality of previous sensor parameters values 356 and corresponding previous wear times 358. The sensor parameter may be, for example, temperature, humidity, barometric pressure, user heart rate and user activity. As illustrated, three previous sensor parameter values 356G, 356H, 356I are depicted. Each of the previous sensor parameter values 356G, 356H, 356I have associated therewith respective wear times. That is, the previous sensor parameter value 356G had a wear time of 3 units of wear time, the previous sensor parameter value 356H had a wear time of 5 units of wear time, and the previous sensor parameter value 356I had a wear time of 7 units of time. Using these previous sensor parameter values 356G, 356H, 356I, a best-fit line 370 may be fitted to these previous sensor parameter values 356G, 356H, 356I. Then, when the current and/or future values of the sensor parameters 338 are obtained, the processor 314 may determine a corresponding actual wear time 344 using the best-fit line 370. This process may be referred to herein as comparing the previous sensor parameter values 356G, 356H, 356I to the current and/or future values of the sensor data parameters 338. For example, if a value of a sensor data parameter 338 has a sensor parameter value 357G, then the processor 314 may determine a wear time of 6 units of wear time.

In embodiments where the previous sensor parameter value 356H is greater than the previous sensor parameter value 356G and/or the previous sensor parameter value 356I is greater than the previous sensor parameter value 356H, the sensor parameter associated with the previous sensor parameter values 356G, 356H, 356I may be positively correlated with wear time. That is, the greater the previous sensor parameter values 356, the longer the wear time. Conversely, the smaller the previous sensor parameter values 356, the shorter the wear time. In embodiments where the previous sensor parameter value 356H is less than the previous sensor parameter value 356G and/or the previous sensor parameter value 356I is less than previous sensor parameter value 356H, the sensor parameter associated with the previous sensor parameter values 356G, 356H, 356I may be negatively correlated with wear time. That is, the smaller the previous sensor parameter values 356, the longer the wear time. Conversely, the greater the previous sensor parameter values 356, the shorter the wear time.

FIG. 17 depicts one exemplary embodiment for determining an equation for actual wear time based on previous wear times 358C, 358D, 358E. This embodiment may be used if the contributions of different sensor parameters to wear time cannot be isolated. To determine an equation for actual wear time 344 according to this embodiment, the processor 314 accesses one or more previous wear times 358C, 358D, 358E. Each of the previous wear time 358C, 358D, 358E has associated therewith previous sensor parameter values 356. Using the previous wear times 358C, 358D, 358E and the associated previous sensor parameter values 35, the processing 314 constructs a system of equations. The processor 314 then solves for the coefficients of the system of equations to determine how much each sensor parameter affects the wear time. Then, the coefficients can be used to construct an equation for actual wear time 344.

As an example for determining an equation for actual wear time 344 using a plurality of previous wear times, assume previous wear times 358C, 358D are functions of two sensor parameters, sensor parameter 1 and sensor parameter 2. In this example, sensor parameter 1 is average temperature and sensor parameter 2 is average humidity during the previous wear times 358C, 358D. For previous wear time 358C, assume the average temperature was x₁, the average humidity was y₁, and the wear time was w₁ units of time. And, for previous wear time 358D, assume the average temperature was x_(z), the average humidity was y₂, and the wear time was w₂ units of time. Using these values, the following system of equations can be generated.

w ₁ =a ₁ *x ₁ +a _(z) *y ₁

w ₂ =a ₁ *x ₂ +a _(z) *y ₂

where a₁ is the contribution to the wear time from sensor parameter 1 and a₂ is the contribution to the wear time from sensor parameter 2. After solving this system of equations for a₁ and a₂, the values of a₁ and a₂ can be used to construct an equation for actual wear time 344. For example, if a sensor 330 projects an average temperature of 20° C. and an average humidity of 50%, then the actual wear time of the base plate by the user will be:

Actual Wear Time=a ₁*20+a ₂*0.50

This process may also be referred to herein as comparing the previous sensor parameter values 356 to the sensor parameters values 357.

FIG. 18 depicts an exemplary flow diagram 400 for determining an ostomy appliance 2 wear time based on sensor data. The flow diagram 400 will be described with reference to FIGS. 1-17. However, any suitable structure can be employed. Although the sub-blocks 402-416 are illustrated, other suitable sub-blocks can be employed to suit different applications. In addition, while the blocks are described in reference to the modules 318, 320, 322, 324 performing tasks, it is the processor 314 that is using the instructions stored in the modules 318, 320, 322, 324 to perform the tasks.

In operation, the operating state module 318 may determine an operating state of the ostomy appliance 2 (e.g., operating state of the base plate 4) (block 402). Alternatively, the accessory device 8 may receive the operating state. The operating state can be indicative of a degree of erosion of the base plate 4. The operating state module 318 may determine the operating state 336 of the base plate 4 to prevent any potential leakage of the ostomy appliance 2.

The sensor module 320 may receive one or more sensor parameters values 357 of sensor data parameters 338 from sensors 330 of the accessory device 8 associated with the ostomy appliance 2 (block 404). The sensor data parameters 338 may include, but are not limited to: temperature data, humidity data, activity data, stoma data, accelerometer data, image data, sound data, input data, and heart-rate data.

Then, based on the operating state 336 and the sensor parameters values 357, the actual wear time module 324 may determine an actual wear time 344 of the ostomy appliance 2, e.g., the base plate 4 (block 406). In embodiments, this may be performed by querying a lookup table (e.g., the wear time lookup table 346) and determining based on the entries of the wear time lookup table 346 an actual wear time 344 that is correlated to the sensor parameters values 357.

Additionally or alternatively, to determine the actual wear time using the operating state 336 and the sensor parameters values 357, the previous wear time module 322 may obtain previous wear times 358 (block 408). The actual wear time module 324 may then adjust the previous wear times 358 to determine the actual wear time 344 (block 410).

To determine an adjustment to the previous wear times 358 to determine the actual wear time 344, the actual wear time module 324 may determine one or more previous sensor parameter values 356 associated with a previous wear time 358 (block 412). The actual wear time module 324 may then compare the previous sensor parameters values 356 to the sensor parameters values 357 (block 414). Based on the comparison, the actual wear time module 324 may determine an actual wear time based on the comparison (block 416). The embodiments described above in relation to FIGS. 16 and 17 are example embodiments for comparing the previous sensor parameters values 356 to the sensor parameters values 357 and determining an actual wear time 344 based on the comparison.

The position of the first connector on the base plate, the number of terminals and the position of the terminals in the coupling part may be adapted to the electrode configuration used in the electrode assembly of the base plate.

FIG. 19 shows an exemplary graphical representation of parameter data as a function of time. In this example, the parameter data in the y-axis is in Volts and time is in the x-axis. Curve 1100 shows, as a function of time, first parameter data indicative of voltage measured by the first electrode pair of the base plate. Curve 1102 shows, as a function of time, second parameter data indicative of voltage measured by the second electrode pair of the base plate. Curve 1104 shows, as a function of time, third parameter data indicative of voltage measured by the third electrode pair of the base plate. Curves 1108, 1116, 1118 show, as a function of time, fourth primary parameter indicative of voltage measured by the fourth electrode pair of the base plate, fourth secondary parameter indicative of voltage measured by the fourth electrode and the fifth electrode of the base plate, and fourth tertiary parameter indicative of voltage measured by the fifth electrode pair of the base plate respectively. Curves 1110, 1112, 1114 show, as a function of time, a gradient of fourth primary parameter indicative of voltage gradient measured by the fourth electrode pair of the base plate, a gradient of fourth secondary parameter indicative of voltage gradient measured by the fourth electrode and the fifth electrode of the base plate, and a gradient of fourth tertiary parameter indicative of voltage gradient measured by the fifth electrode pair of the base plate respectively. FIG. 19 shows the upper voltage threshold value represented as curve 1000, the medium voltage threshold value represented as curve 1002, the lower voltage threshold value represented as curve 1004, and curve 1006 is a gradient limit.

Curves 1108, 1116, 1118 as well as curves 1110, 1112, 1114 show that no moisture is detected at the proximal side of the first adhesive layer by the fourth electrode pair.

At a time less than 5 h, curve 1100 shows that moisture is detected by the first electrode pair as the first parameter data crosses the upper voltage threshold value while curve 1102 shows that moisture is not detected by the second electrode pair as the second parameter data has not crossed the upper voltage threshold value. At this stage, it is determined that the ostomy appliance is in a first operating state.

At time between 5 h and 10 h, curve 1102 shows that moisture is detected by the second electrode pair as the second parameter data crosses the upper voltage threshold value. At this stage, it is determined that the ostomy appliance is in a second operating state.

At time around 45 h, curve 1104 shows that moisture is detected by the third electrode pair as the third parameter data crosses the upper voltage threshold value. At this stage, it is determined that the ostomy appliance is in a third operating state.

FIG. 20 shows an exemplary graphical representation of parameter data as a function of time. In this example, the parameter data in the y-axis is in Volts and time is in the x-axis. Curve 1202 shows, as a function of time, first parameter data indicative of voltage measured by the first electrode pair of the base plate. Curve 1204 shows, as a function of time, second parameter data indicative of voltage measured by the second electrode pair of the base plate. Curve 1200 shows, as a function of time, third parameter data indicative of voltage measured by the third electrode pair of the base plate. Curves 1206, 1208, 1210 show, as a function of time, fourth primary parameter indicative of voltage measured by the fourth electrode pair of the base plate, fourth secondary parameter indicative of voltage measured by the fourth electrode and the fifth electrode of the base plate, and fourth tertiary parameter indicative of voltage measured by the fifth electrode pair of the base plate respectively. Curves 1212, 1214, 1216 show, as a function of time, a gradient of fourth primary parameter indicative of voltage gradient measured by the fourth electrode pair of the base plate, a gradient of fourth secondary parameter indicative of voltage gradient measured by the fourth electrode and the fifth electrode of the base plate, and a gradient of fourth tertiary parameter indicative of voltage gradient measured by the fifth electrode pair of the base plate respectively. FIG. 20 shows the upper voltage threshold value represented as curve 1000, the medium voltage threshold value represented as curve 1002, the lower voltage threshold value represented as curve 1004, and curve 1006 represents a gradient limit.

Curves 1206, 1208, 1210 as well as curves 1212, 1214, 1216 show that moisture is detected at the proximal side of the first adhesive layer by the fourth electrode pair, the fourth and fifth electrode, and the fifth electrode pair at a time starting at 60 h until 90 h. As the three electrode pairs are triggered as shown by the decreases shown by 1206, 1208, 1210 and as the curves 1212, 1214, 1216 show a gradient below 80%, this is indicative of the presence of sweat at the proximal side of the first adhesive layer.

At a time of 30 min, curve 1202 shows that moisture is detected by the first electrode pair as the first parameter data crosses the upper voltage threshold value while curve 1204 shows that moisture is not detected by the second electrode pair as the second parameter data has not crossed the upper voltage threshold value. At this stage, it is determined that the ostomy appliance is in a first operating state.

At time around 40 h, curve 1204 shows that moisture is detected by the second electrode pair as the second parameter data crosses the upper voltage threshold value. At this stage, it is determined that the ostomy appliance is in a second operating state.

FIG. 21 shows an exemplary graphical representation of parameter data as a function of time. In this example, the parameter data in the y-axis is in Volts and time is in the x-axis. Curve 1300 shows, as a function of time, first parameter data indicative of voltage measured by the first electrode pair of the base plate. Curve 1302 shows, as a function of time, second parameter data indicative of voltage measured by the second electrode pair of the base plate. Curve 1304 shows, as a function of time, third parameter data indicative of voltage measured by the third electrode pair of the base plate. Curves 1306, 1308, 1310 show, as a function of time, fourth primary parameter indicative of voltage measured by the fourth electrode pair of the base plate, fourth secondary parameter indicative of voltage measured by the fourth electrode and the fifth electrode of the base plate, and fourth tertiary parameter indicative of voltage measured by the fifth electrode pair of the base plate respectively. Curves 1312, 1314, 1316 show, as a function of time, a gradient of fourth primary parameter indicative of voltage gradient measured by the fourth electrode pair of the base plate, a gradient of fourth secondary parameter indicative of voltage gradient measured by the fourth electrode and the fifth electrode of the base plate, and a gradient of fourth tertiary parameter indicative of voltage gradient measured by the fifth electrode pair of the base plate respectively. FIG. 21 shows the upper voltage threshold value represented as curve 1000, the medium voltage threshold value represented as curve 1002, the lower voltage threshold value represented as curve 1004, and curve 1006 is a gradient limit.

Curves 1306, 1308, 1310 as well as curves 1312, 1314, 1316 show that moisture is detected at the proximal side of the first adhesive layer by the fourth electrode pair at a time starting at around 25 h. As leakage electrodes (i.e. the fourth electrode pair, the fourth and fifth electrode, and the fifth electrode pair) are trigger as shown by the decreases shown by 1306, 1308, 1310 and as curve 1312, 1314, 1316 show a gradient above 80%, this is indicative of the presence of output at the proximal side of the first adhesive layer. This indicate severe leakage. It may be determined that the ostomy appliance is in a sixth operating state.

At a time of 5 h, curve 1300 shows that moisture is detected by the first electrode pair as the first parameter data crosses the upper voltage threshold value while curve 1302 shows that moisture is not detected by the second electrode pair as the second parameter data has not crossed the upper voltage threshold value. At this stage, it is determined that the ostomy appliance is in a first operating state.

At time around 15 h, curve 1302 shows that moisture is detected by the second electrode pair as the second parameter data crosses the upper voltage threshold value. At this stage, it is determined that the ostomy appliance is in a second operating state.

At time around 30 h, curve 1304 shows that moisture is detected by the third electrode pair as the third parameter data crosses the upper voltage threshold value. In an example where the curves 1306, 1308, 1310 had not dropped below corresponding thresholds, curve 1304 indicates that moisture has reached the third electrode pair, and the present disclosure enables determining that the ostomy appliance is in a third operating state.

FIG. 22 shows an exemplary graphical representation of parameter data as a function of time and a whitening zone diameter (e.g. related to a radial thickness of a whitening ring surrounding the stomal opening) as a function of time. FIG. 22 illustrates the moisture propagation in the first adhesive layer as a function of time and illustrates a correlation between parameter data detected by the first electrode pair and the second electrode pair of the base plate and actual moisture on the proximal surface of the first adhesive layer of the base plate. The actual moisture propagation in the first adhesive layer may appear as a whitening zone (e.g. a white ring around the stomal opening) in the first adhesive layer. Moisture affects the first adhesive layer in that the moisture reacts with the composition of the first adhesive layer to form the white ring around the stomal opening, and thereby reduces adhesive performance of the base plate. FIG. 22 is obtained by experiments where water is applied from the stomal opening of the base plate to follow, using the electrodes of the base plate, the radial propagation of moisture leading to radial erosion of the first adhesive layer of the base plate.

Curve 1502 shows, as a function of time, first parameter data indicative of voltage measured by the first electrode pair of the base plate. Curve 1504 shows, as a function of time, second parameter data indicative of voltage measured by the second electrode pair of the base plate. Curve 1506 shows a diameter of the white ring as a function of time. The first parameter data shows a decrease in e.g. voltage measured by the first electrode pair over time. It is also seen that the voltage of the second electrode pair drops at a later time than when the first parameter data shows a decrease in e.g. voltage dropped. This correlates well with the diameter of the white ring which goes from around 25-26 mm when the first electrode pair is triggered (e.g. first parameter data shows a decrease) to 38 mm when the second electrode pair is triggered (second parameter data shows a decrease). This corresponds substantially to the location of the first electrode pair at twice the first radial distance R1, and of the second electrode pair at twice the second radial distance R2.

It is noted that various regions and countries have various routines and recommendations to support optimal use of an ostomy appliance. For example, in regions of Europe, it may be indicated to the user that an ostomy appliance with a base plate as disclosed herein is an optimal state (corresponding to a first operating state) when the radial thickness of the whitening ring is between 0-15 mm (for a user not in compliance with a preferred use), such as between 0-7 mm (for a user in compliance with a preferred use), such as between 0-5 mm (recommended by a nurse).

For example, in Europe, it may be indicated to the user that an ostomy appliance with a base plate as disclosed herein is in suboptimal state (corresponding to a second operating state) and thereby indicate a consideration to change the base plate when the radial thickness of the whitening ring is such as between 5-10 mm (recommended by a nurse), between 7 mm and 10 mm (for a user in compliance with a preferred use), and/or between 15 mm and 30 mm (for a user not in compliance with a preferred use).

For example, in Europe, it may be indicated to the user that an ostomy appliance with a base plate as disclosed herein is in a poor state (corresponding to a third operating state) and indicate a request to change the base plate when the radial thickness of the whitening ring is more than 10 mm (recommended by a nurse), such as more than 15 mm (for a user in compliance with a preferred use), such as more than 30 mm (for a user not in compliance with a preferred use).

For example, in other regions (e.g. America), it may be indicated to the user that an ostomy appliance with a base plate as disclosed herein is an optimal state (corresponding to a first operating state) when the radial thickness of the whitening ring is between 0-20 mm (for a user not in compliance with a preferred use), such as between 0-10 mm (for a user in compliance with a preferred use), such as between 0-10 mm (recommended by a nurse).

For example, in other regions (e.g. America), it may be indicated to the user that an ostomy appliance with a base plate as disclosed herein is in suboptimal state (corresponding to a second operating state) and thereby indicate a consideration to change the base plate when the radial thickness of the whitening ring is such as between 10 mm and 20 mm (recommended by a nurse), between 10 mm and 20 (for a user in compliance with a preferred use), and/or between 20 mm and 40 mm (for a user not in compliance with a preferred use).

For example, in other regions (e.g. America), it may be indicated to the user that an ostomy appliance with a base plate as disclosed herein is in a poor state (corresponding to a third operating state) and indicate a request to change the base plate when the radial thickness of the whitening ring is more than 20 mm (recommended by a nurse), such as more than 20 mm (for a user in compliance with a preferred use), such as more than 40 mm (for a user not in compliance with a preferred use).

The disclosed methods, ostomy appliances, monitor devices, and accessory devices allow to accommodate the regional preferences of user in their use of the ostomy appliance so as to adjust thresholds for the operating states to the regional preference or use.

For example, if a sensor parameter value is sensed in a first region where it is customary to wear an ostomy appliance for a shorter duration (e.g., Europe) in comparison to a second region where it is customary to wear an ostomy appliance for a longer duration (e.g., America), a scaling factor may be applied that decreases the actual wear time of the ostomy appliance (e.g. wear time of the base plate disclosed herein) based on the specific sensor parameter value in comparison to if the ostomist or ileostomist were located in the second region and the same sensor parameter value were sensed, whereas if the ostomist or ileostomist is located in the second region then a second scaling factor may be applied that increases the actual wear time of the ostomy appliance (e.g. wear time of the base plate disclosed herein) in comparison to if the ostomist or ileostomist were located in the first region based on the same sensor parameter value being sensed.

As another example, if an ostomist or ileostomist relocates from the second region to the first region, a first scaling factor may be applied that decreases the actual wear time of the ostomy appliance (e.g. wear time of the base plate disclosed herein) in comparison to a previous wear time based on the same sensor parameter value being sensed. Conversely, if the ostomist or ileostomist relocates from the first region to the second region then a second scaling factor may be applied that increases the actual wear time of the ostomy appliance (e.g. wear time of the base plate disclosed herein) in comparison to a previous wear time based on the same sensor parameter value being sensed.

FIGS. 23A-23B shows exemplary graphical representations of peel force as a function of a peeling distance traveled by a peeling action exercising the peel force (e.g. perpendicularly to the proximal (or distal) surface of the first adhesive layer) on a first adhesive layer of a base plate disclosed herein. The peel force relates to a required force to peel the first adhesive layer off the skin surface. The peeling distance is with respect to one end of the first adhesive layer where the peel force starts to be exercised. The peeling distance relates to the size or length of the first adhesive layer and thereby may relate to a size or length of a portion the first adhesive layer affected by moisture and of a portion of the first adhesive layer not affected by moisture. The peel forces illustrated in FIGS. 23A-23B are representative of adhesive performance of the first adhesive layer of the base plate to the skin surface.

Composition of the first adhesive layer of the base plate as disclosed herein in one or more embodiments is formulated to provide adhesion of the base plate to the skin surface of the user when the base plate is worn and to maintain a dry and healthy skin surface. Avoiding maceration of skin when occluding the skin with an adhesive is done by transporting sweat away from the skin and into the first adhesive layer by means of e.g. hydrocolloid types and adhesive (e.g. hydrocolloid adhesives) forming part of an absorbing element of the first adhesive layer.

For example, when the absorbing element is in contact with moisture, (e.g. water, sweat, urine or faeces), the absorbing element absorb the moisture. This reduces the adhesion of the first adhesive layer to the skin.

For example, the first adhesive layer goes from a dry adhesive state with acceptable adhesive performance (e.g. acceptable adhesion and cohesion) in to a wet adhesive state (e.g. reduced or non-adhesion and low cohesion gel).

Curve 1602 of FIGS. 23A and 23B shows a peel force applied to the first adhesive layer as a function of a peeling distance traveled by a peeling action exercising the peel force on the first adhesive layer in a dry adhesive state, (e.g. not affected by moisture). The peel force is expressed in Newtons while the peeling distance is expressed in mm. The length of the first adhesive layer in dry adhesive state is illustrated by X5, corresponding to length of the first adhesive layer 1608 in dry adhesive state.

Curve 1602 shows that the peel force applied to the first adhesive layer in a dry adhesive state is equal to Y1 when the peeling distance is less than X1. At X1, the peeling force drops as the peeling distance increases towards X5 and the end of the first adhesive layer.

Curve 1604 of FIG. 23A shows a peel force applied to the first adhesive layer as a function of a peeling distance traveled by a peeling action exercising the peel force on the first adhesive layer in a wet adhesive state, (e.g. affected by moisture to the point of reaching a completely wet adhesive state, where the first adhesive layer has become a gel).

Curve 1604 shows that when the peeling distance is less than X2, the peel force applied to the first adhesive layer in a wet adhesive state is equal to Y2 which has much lower value than Y1. This shows that the adhesive performance of the first adhesive layer is reduced when the first adhesive layer is in a wet adhesive state. At X2, the peeling force drops as the peeling distance increases until the end of the first adhesive layer. It is noted that X2 is larger than X1, because the first adhesive layer in a wet adhesive state extends in volume, and thus in length due to the gelling of the components of the first adhesive layer.

The peel experiment illustrated in FIG. 23A shows a loss of adhesive performance when the first adhesive is in a wet adhesive state.

Curve 1606 of FIG. 23B shows a peel force applied to the first adhesive layer as a function of a peeling distance traveled by a peeling action exercising the peel force on the first adhesive layer illustrated 1610 which comprises a first portion 1610A in a dry adhesive state and a second portion 1610B in a wet adhesive state, (e.g. affected by moisture to the point of reaching a completely wet adhesive state, where the first adhesive layer has become a gel).

Curve 1606 shows that when the peeling distance is less than X3, the peel force applied to the first adhesive layer in a wet adhesive state is equal to Y3 which has lower value than Y1. This shows that the adhesive performance of the first adhesive layer is reduced when the first adhesive layer comprises a portion in a wet adhesive state. At X3, the peeling force drops as the peeling distance increases until the end of the first adhesive layer. It is noted that X3 corresponds to the length of the portion 1610A in dry adhesive state.

The peel experiment illustrated in FIG. 23B shows a loss of adhesive performance when the first adhesive is partly in a wet adhesive state. As such, the wear time of the ostomy appliance (e.g. wear time of the base plate disclosed herein) may be adjusted based on sensor parameter values being sensed that indicates more or less humidity.

For example, if a first sensor parameter value is sensed that corresponds to a higher humidity than a second sensor parameter value being sensed, a first scaling factor may be applied that decreases the actual wear time of the ostomy appliance (e.g. wear time of the base plate disclosed herein) in comparison to if the second sensor parameter value were sensed, whereas if the second sensor parameter value is sensed then a second scaling factor may be applied that increases the actual wear time of the ostomy appliance (e.g. wear time of the base plate disclosed herein) in comparison to if the first sensor parameter value being sensed.

As another example, if a sensor parameter value is sensed that indicates a higher humidity than the humidity that was sensed when a previous wear time was calculated, a first scaling factor may be applied that decreases the actual wear time of the ostomy appliance (e.g. wear time of the base plate disclosed herein) in comparison to the previous wear time. Conversely, if a sensor parameter value is sensed that indicates a lower humidity than the humidity that was sensed when a previous wear time was calculated, then a second scaling factor may be applied that increases the actual wear time of the ostomy appliance (e.g. wear time of the base plate disclosed herein) in comparison to the previous wear time.

Accordingly, FIGS. 23A-23B demonstrate that the operating state determined based on monitor data is indicative of adhesive performance of the base plate.

FIGS. 24A-24B show exemplary graphical representations of a whitening zone diameter (e.g. related to a radial thickness of a whitening ring surrounding the stomal opening) as a function of time. FIGS. 24A-24B illustrate the moisture propagation in the first adhesive layer as a function of time and illustrates a diametral velocity of the moisture propagation on the proximal surface of the first adhesive layer of the base plate. The actual moisture propagation in the first adhesive layer may appear as a whitening zone (e.g. a white ring around the stomal opening) in the first adhesive layer. FIGS. 24A-24B show measurements of a diameter of the whitening zone as a function of time as moisture propagates. Moisture affects the first adhesive layer in that the moisture reacts with the composition of the first adhesive layer to form the white ring around the stomal opening, and thereby reduces adhesive performance of the base plate.

FIG. 24A is obtained by experiments where water is applied from the stomal opening of the base plate of a first type to measure a velocity of the radial propagation of moisture leading to radial erosion of the first adhesive layer of the base plate of the first type.

FIG. 24B is obtained by experiments where water is applied from the stomal opening of the base plate of a second type to measure a velocity the radial propagation of moisture leading to radial erosion of the first adhesive layer of the base plate of the second type. The second type is different from the first type, in that the composition of the first adhesive layer may be different than the first adhesive layer of the second type when compared to the first type.

Curve 2104 shows, as a function of time, a diameter of the white ring of a base plate of the first type measured from a cut for a stomal opening to the first electrode pair.

Curve 2102 shows a linear approximation of curve 2104, and thereby characterizes the velocity from the cut to the first electrode pair. The linear approximation may be formulated as a linear equation of the type Y=v01*X+A, where Y is the diameter of the white ring in millimetres (mm), X is time in hours, v01 is a diametral velocity of propagation of moisture in the base plate of the first type from the cut to the first electrode pair, and A relates to the diameter of the cut. In the experiment illustrated in FIG. 24A, v01=0.6 mm/h and A is 22 (i.e. the cut for the stomal opening has a diameter of 22 mm). Other experiments have shown that v01 may be in the range of 0.5 mm/h to 0.8 mm/h, with an average diametral velocity v01 of 0.65 mm/h for moisture to propagate from the cut to the first electrode pair. To obtain radial velocity V01 for moisture to propagate from the cut to the first electrode pair from the results of FIG. 24A, the diametral velocity v01 is to be divided by two: V01=0.3 mm/h for the illustrated experiment.

Curve 2106 shows, as a function of time, a diameter of the white ring of a base plate of the first type measured from the first electrode pair to the second electrode pair.

Curve 2108 shows a linear approximation of curve 2106, and thereby characterizes the velocity from the first electrode pair to the second electrode pair. The linear approximation may be formulated as a linear equation of the type Y=v12*X+B, where Y is the diameter of the white ring in millimetres (mm), X is time in hours, v12 is a diametral velocity of propagation of moisture in the base plate of the first type from the first electrode pair to the second electrode pair, and B relates to approximate location of the first electrode pair from the center of the stomal opening. In the experiment illustrated in FIG. 24A, v12=0.2 mm/h and B is 27.3 mm (i.e. the first electrode pair is place around 27.3 mm). Other experiments have shown that v12 may be in the range of 0.15 mm/h to 0.22 mm/h, with an average diametral velocity of 0.18 mm/h for moisture to propagate from the first electrode pair to the second electrode pair. To obtain radial velocity V12 for moisture to propagate from the first electrode pair to the second electrode pair from the results of FIG. 24A, the diametral velocity v12 is to be divided by two: V12=0.1 mm/h for the illustrated experiment.

Curve 2112 shows, as a function of time, a diameter of the white ring of a base plate of the second type measured from a cut for a stomal opening to the first electrode pair.

Curve 2110 shows a linear approximation of curve 2112, and thereby characterizes the velocity from the cut to the first electrode pair. The linear approximation may be formulated as a linear equation of the type Y=v01*X+A, where Y is the diameter of the white ring in millimetres (mm), X is time in hours, v01 is a diametral velocity of propagation of moisture in the base plate of the second type from the cut to the first electrode pair, and A relates to the diameter of the cut. In the experiment illustrated in FIG. 24B, v01=0.3 mm/h and A is 21.9 (i.e. the cut for the stomal opening has a diameter of 21.9 mm). Other experiments have shown that v01 may be in the range of 0.2 mm/h to 0.32 mm/h, with an average diametral velocity v01 of 0.275 mm/h for moisture to propagate from the cut to the first electrode pair. To obtain radial velocity V01 for moisture to propagate from the cut to the first electrode pair from the results of FIG. 24B, the diametral velocity v01 is to be divided by two: V01=0.15 mm/h for the illustrated experiment.

Curve 2114 shows, as a function of time, a diameter of the white ring of a base plate of the second type measured from the first electrode pair to the second electrode pair.

Curve 2116 shows a linear approximation of curve 2114, and thereby characterizes the velocity from the first electrode pair to the second electrode pair. The linear approximation may be formulated as a linear equation of the type Y=v12*X+B, where Y is the diameter of the white ring in millimetres (mm), X is time in hours, v12 is a diametral velocity of propagation of moisture in the base plate of the second type from the first electrode pair to the second electrode pair, and B relates to approximate location of the first electrode pair from the center of the stomal opening. In the experiment illustrated in FIG. 24B, v12=0.2 mm/h and B is 25.9 mm (i.e. the first electrode pair is place around 25.9 mm). Other experiments have shown that v12 may be in the range of 0.15 mm/h to 0.22 mm/h, with an average diametral velocity of 0.1 mm/h for moisture to propagate from the first electrode pair to the second electrode pair. To obtain radial velocity V12 for moisture to propagate from the first electrode pair to the second electrode pair from the results of FIG. 24B, the diametral velocity v12 is to be divided by two: V12=0.5 mm/h for the illustrated experiment.

The experiments illustrated in FIGS. 24A-24B correspond substantially with the location of the first electrode pair at twice the first radial distance R1, and of the second electrode pair at twice the second radial distance R2.

The present disclosure exploits the derivable velocities to determine an operating state based on sensor data. As such, a scaling factor may be applied to determine an operating state based on sensor parameter values that either decrease or increase the propagation velocity based on how the sensor data affects propagation speed, which correlates to wear time of the ostomy appliance (e.g. wear time of the base plate disclosed herein). For example, if a first sensor parameter value is sensed that corresponds to a faster propagation speed than if a second sensor parameter value were sensed, then a scaling factor can be applied that decreases the wear time of the ostomy appliance (e.g. wear time of the base plate disclosed herein). Conversely, if the second sensor parameter value is sensed corresponding to a slower propagation speed, then a scaling factor can be applied that increases the wear time of the ostomy appliance (e.g. wear time of the base plate disclosed herein).

FIG. 25A show an exemplary graphical representation of first parameter data as a function of time. In this example, the parameter data in the y-axis is in millivolts and time is in the x-axis.

FIG. 25A is obtained by experiments where semi-solid matter with various degrees of dilution is applied from the stomal opening of the base plate to follow, using the first electrode pair of the base plate, the radial propagation of moisture leading to radial erosion of the first adhesive layer of the base plate. Dilution is performed with tap water and semi-solid matter.

The exemplary results of FIG. 25A illustrates and mimics how the moisture content of the output would affect the first parameter data and thereby the operating state. This is done by mixing a semi-solid matter with water to various dilution factors. The content of moisture in real life changes the viscosity of the output and is affected by one or more factors: nutrition (type of food eaten by user, water intake, etc.), medication (e.g. vitamins/supplements, prescriptions, etc.), and health data (e.g. medical conditions of the user, diseases, ostomist, ileostomist, etc.).

Curve 2202 shows, as a function of time, first parameter data indicative of voltage measured by the first electrode pair of the base plate when a mixture of 0% semi-solid matter and 100% tap water is applied from the stomal opening of the base plate.

Curve 2204 shows, as a function of time, first parameter data indicative of voltage measured by the first electrode pair of the base plate when a mixture of 30% semi-solid matter and 70% tap water is applied. Curve 2204A shows, as a function of time, first parameter data indicative of voltage measured by the first electrode pair of the base plate when a mixture of 30% semi-solid matter and 70% tap water is applied.

Curve 2206 shows, as a function of time, first parameter data indicative of voltage measured by the first electrode pair of the base plate when a mixture of 30% semi-solid matter and 70% tap water is applied.

Curve 2208 shows, as a function of time, first parameter data indicative of voltage measured by the first electrode pair of the base plate when a mixture of 50% semi-solid matter and 50% tap water is applied.

Curve 2210 shows, as a function of time, first parameter data indicative of voltage measured by the first electrode pair of the base plate when a mixture of 100% semi-solid matter and 0% tap water is applied.

Curve 2212 shows, as a function of time, first parameter data indicative of voltage measured by the first electrode pair of the base plate when a mixture of 100% semi-solid matter and 0% tap water is applied.

It may be noted that the more diluted the output is the earlier the first electrode pair is triggered.

FIG. 25B shows exemplary graphical representations of first parameter data as a function of percentage of output in the mixture applied.

Curve 2214 shows a linear approximation relating the trigger times of the first electrode pair to the percentage of semi-solid matter, and thereby characterizes how the viscosity of the semi-solid matter affects the propagation of moisture in the first adhesive layer. The curve 2214 represents a linear equation with a coefficient of 10.6 with an approximation precision of 87% for the exemplary results. This supports a determination of an operating state based one or more of: nutrition (type of food eaten by user, water intake, etc.), health data (e.g. medical conditions of the user, diseases, ostomist, ileostomist, etc.), and activity level (e.g., sports bending, movement). This may enable determining the actual wear time by performing an adjustment to the previous wear time based on the sensor parameter value. Adjustment may be performed by applying one or more scaling factors illustrated herein and associated with the one or more corresponding sensor parameter values.

For example, if a first sensor parameter value (e.g., type of food, medicine and/or water intake) is sensed that corresponds to output that is less viscous than a second sensor parameter value being sensed, a first scaling factor may be applied that decreases the actual wear time of the ostomy appliance (e.g. wear time of the base plate disclosed herein) in comparison to if the second sensor parameter value were sensed, whereas if the second sensor parameter value is sensed then a second scaling factor may be applied that increases the actual wear time of the ostomy appliance (e.g. wear time of the base plate disclosed herein) in comparison to if the first sensor parameter value being sensed.

As another example, if a sensor parameter value (e.g., type of food, medicine and/or water intake) is sensed that corresponds to less viscous output than a sensor parameter value that was sensed when a previous wear time was calculated, a first scaling factor may be applied that decreases the actual wear time of the ostomy appliance (e.g. wear time of the base plate disclosed herein) in comparison to the previous wear time.

Conversely, if a sensor parameter value is sensed that indicates a more viscous output than a sensor parameter value that was sensed when a previous wear time was calculated, then a second scaling factor may be applied that increases the actual wear time of the ostomy appliance (e.g. wear time of the base plate disclosed herein) in comparison to the previous wear time.

Regarding activity level, which may be determined using sensor data, experimental results have shown that the operating state may be affected negatively by a reducing factor ranging from 2 to 10 compared to when the user has no or little activity (e.g. a sedentary user). For example, a wear time may be reduced by a factor of 2 to 10 due to an extensive activity. For example, if a first sensor parameter value is sensed that corresponds to a higher activity level than a second sensor parameter value being sensed, a first scaling factor may be applied that decreases the actual wear time of the ostomy appliance (e.g. wear time of the base plate disclosed herein) in comparison to if the second sensor parameter value were sensed, whereas if the second sensor parameter value is sensed then a second scaling factor may be applied that increases the actual wear time of the ostomy appliance (e.g. wear time of the base plate disclosed herein) in comparison to if the first sensor parameter value being sensed.

As another example, if a sensor parameter value is sensed that indicates a higher activity than the activity level that was sensed when a previous wear time was calculated, a first scaling factor may be applied that decreases the actual wear time of the ostomy appliance (e.g. wear time of the base plate disclosed herein) in comparison to the previous wear time. Conversely, if a sensor parameter value is sensed that indicates a lower activity level than the activity level that was sensed when a previous wear time was calculated, then a second scaling factor may be applied that increases the actual wear time of the ostomy appliance (e.g. wear time of the base plate disclosed herein) in comparison to the previous wear time.

It may be envisaged that a thin output may be detected based on the early triggering time of the first electrode pair and thereby the actual operating state may be determined accordingly.

FIG. 26A shows an exemplary graphical representation 2302 of parameter data as a function of time for a first type of base plate at a first predetermined temperature. The first predetermined temperature in the example depicted in FIG. 26A is 32 degrees Celsius. FIG. 26B shows an exemplary graphical representation 2304 of parameter data as a function of time for the first type of base plate at a second predetermined temperature. The second predetermined temperature in the example depicted in FIG. 26B is 37 degrees Celsius. The temperatures were selected to closely approximate human skin temperature.

FIGS. 26A and 26B were obtained by applying fluid at a stomal opening of a base plate, wherein the stomal opening had a diameter of 22 mm. The residual humidity of the environment for both experiments was 50%. As the fluid was absorbed by the base plate over time and the fluid propagated radially from the stomal opening outward, parameter data (e.g. voltages (mV)) was measured between a first electrode pair, a second electrode pair, and/or a third electrode pair respectively.

Specifically, in FIG. 26A, curve 2306 shows, as a function of time, a decrease in voltage for the first electrode pair at approximately 8.3 hours. Curve 2308 shows, as a function of time, a constant voltage for the second electrode pair. And, curve 2310 shows, as a function of time, a constant voltage for the third electrode pair.

By comparison, in FIG. 26B, curve 2312 shows a decrease in voltage for the first electrode pair at approximately 7.6 hours. Curve, 2314 shows, as a function of time, a constant voltage for the second electrode pair. And, curve 2316 shows, as a function of time, a constant voltage for the third electrode pair.

Stated another way, in this example, moisture propagated approximately 11% faster when the temperature was 37 degrees Celsius in comparison to when the temperature was 32 degrees Celsius. This comparison shows that as temperature increases, wear time of the base plate decreases due to faster moisture propagation and adhesion degradation.

Another experiment was conducted where the propagation speed of fluid, applied at the stomal opening of a second type of base plate, was measured. Similar to the experiment depicted in FIGS. 26A, 26B, the stomal opening had a diameter of 22 mm and the residual humidity of the environment was 50%. The second type of base plate is different than the first type of base plate, in that the composition of the first adhesive layer of the first type of base plate is different than the composition of the first adhesive layer of the second type of base plate.

In this experiment, the fluid propagated between center of the hole and first electrode pair at approximately 0.15 mm/hour when the temperature was 32 degrees Celsius. In comparison, the fluid propagated at approximately 0.2 mm/hour when the temperature was 37 degrees Celsius. As such, this experiment similarly found that for another type of base plate as temperature increases, wear time of the second type of base plate decreases due to faster moisture propagation and adhesion degradation.

In view of the above results, a scaling factor may be applied to the operating state (e.g. wear time) of a base plate such that the scaling factor affects negatively the operating state (e.g. decreases the wear time) of the base plate as temperature increases and/or the scaling factor affects positively the operating state (e.g. increases the wear time) of the base plate as temperature decreases.

In some embodiments, the scaling factor may be predetermined. In these embodiments, the predetermined scaling factor may be constant. Alternatively, the predetermined scaling factor may be iteratively adjusted based on when the first electrode pair, the second electrode pair, and/or the third electrode pair are triggered. In at least some of these embodiments, the predetermined scaling factor may be iteratively adjusted.

In view of the above results, people located in a hotter climate may have a reduced wear time and/or a scaling factor applied that decreases the wear time in comparison to people located in a cooler climate. A sensor parameter value indicative of temperature may lead to an adjustment to the previous wear time (e.g. using corresponding scaling factors) to determine the actual wear time.

For example, if a first sensor parameter value is sensed that corresponds to a higher temperature than a second sensor parameter value being sensed, a first scaling factor may be applied that decreases the actual wear time of the ostomy appliance (e.g. wear time of the base plate disclosed herein) in comparison to if the second sensor parameter value were sensed, whereas if the second sensor parameter value is sensed then a second scaling factor may be applied that increases the actual wear time of the ostomy appliance (e.g. wear time of the base plate disclosed herein) in comparison to if the first sensor parameter value being sensed.

As another example, if a sensor parameter value is sensed that indicates a higher temperature than the temperature that was sensed when a previous wear time was calculated, a first scaling factor may be applied that decreases the actual wear time of the ostomy appliance (e.g. wear time of the base plate disclosed herein) in comparison to the previous wear time. Conversely, if a sensor parameter value is sensed that indicates a lower temperature than the temperature that was sensed when a previous wear time was calculated, then a second scaling factor may be applied that increases the actual wear time of the ostomy appliance (e.g. wear time of the base plate disclosed herein) in comparison to the previous wear time. The use of the terms “first”, “second”, “third” and “fourth”, “primary”, “secondary”, “tertiary” etc. does not imply any particular order, but are included to identify individual elements. Moreover, the use of the terms “first”, “second”, “third” and “fourth”, “primary”, “secondary”, “tertiary” etc. does not denote any order or importance, but rather the terms “first”, “second”, “third” and “fourth”, “primary”, “secondary”, “tertiary” etc. are used to distinguish one element from another. Note that the words “first”, “second”, “third” and “fourth”, “primary”, “secondary”, “tertiary” etc. are used here and elsewhere for labelling purposes only and are not intended to denote any specific spatial or temporal ordering. Furthermore, the labelling of a first element does not imply the presence of a second element and vice versa.

Although particular features have been shown and described, it will be understood that they are not intended to limit the claimed invention, and it will be made obvious to those skilled in the art that various changes and modifications may be made without departing from the spirit and scope of the claimed invention. The specification and drawings are, accordingly to be regarded in an illustrative rather than restrictive sense. The claimed invention is intended to cover all alternatives, modifications and equivalents.

LIST OF REFERENCES

-   1 ostomy system -   2 ostomy appliance -   4 base plate -   6 monitor device -   8 accessory device -   10 server device -   12 network -   14 coupling member -   16 coupling ring -   18, 18A, 18B, 18C, 18D stomal opening -   20 docking station -   22 first connector -   24 user interface -   100 monitor device housing -   101 processor -   102 first interface -   104 second interface -   106 memory -   108 ground terminal of monitor device -   110 first terminal of monitor device -   112 second terminal of monitor device -   114 third terminal of monitor device -   116 fourth terminal of monitor device -   118 fifth terminal of monitor device -   120 coupling part -   121 power unit -   122 antenna -   124 wireless transceiver -   126 loudspeaker -   128 haptic feedback element -   140 sensor unit -   142 sensor data -   144 first sensor -   146 second sensor -   200 first adhesive layer -   200A distal side/surface of first adhesive layer -   200B proximal side/surface of first adhesive layer -   202 second adhesive layer -   202A distal side/surface of second adhesive layer -   202B proximal side/surface of second adhesive layer -   204 electrode assembly -   204A distal side/surface of electrode assembly -   204B proximal side/surface of electrode assembly -   206 release liner -   206A distal side/surface of the release liner -   206B proximal side/surface of the release liner -   208 top layer -   208A distal side/surface of the top layer -   208B proximal side/surface of the top layer -   209 coupling ring -   210 coupling part of first connector -   211 first connector -   212 terminals of first connector -   213 first intermediate element -   213A distal side/surface of first intermediate element -   213B proximal side/surface of first intermediate element -   214 support layer of electrode assembly -   214A distal side/surface of support layer -   214B proximal side/surface of support layer -   216 electrodes of electrode assembly -   217 connection parts of electrodes -   218, 219 masking element -   218A distal side/surface of masking element -   218B proximal surface of masking element -   220, 220A, 220B electrode configuration -   222 ground electrode -   222A ground connection part -   222B ground sensing part -   222C ground connector part -   224 first electrode -   224A first connection part -   224B first sensing part -   224C first conductor part -   226 second electrode -   226A second connection part -   226B second sensing part -   226C second conductor part -   228 third electrode -   228A third connection part -   228B third sensing part -   228C third conductor part -   230 fourth electrode -   230A fourth connection part -   230B fourth sensing part -   232 fifth electrode -   232A fifth connection part -   232B fifth sensing part -   234 first electrode part of the ground electrode -   236 second electrode part of the ground electrode -   238 third electrode part of the ground electrode -   240 fourth electrode part of the ground electrode -   242 ground terminal opening -   244 first terminal opening -   246 second terminal opening -   248 third terminal opening -   250 fourth terminal opening -   252 fifth terminal opening -   254 primary sensor point openings of masking element -   254A primary first sensor point opening -   254B primary second sensor point opening -   256 secondary sensor point openings of masking element -   256A secondary first sensor point opening -   256B secondary second sensor point opening -   258 tertiary sensor point openings of masking element -   258A tertiary first sensor point opening -   258B tertiary second sensor point opening -   260 primary sensor point openings of first adhesive layer -   260A primary first sensor point opening -   260B primary second sensor point opening -   262 secondary sensor point openings of first adhesive layer -   262A secondary first sensor point opening -   262B secondary second sensor point opening -   264 tertiary sensor point openings of first adhesive layer -   264A tertiary first sensor point opening -   264B tertiary second sensor point opening -   282 ground terminal element -   282A ground terminal -   284 first terminal element -   284A first terminal -   286 second terminal element -   286A second terminal -   288 third terminal element -   288A third terminal -   290 fourth terminal element -   290A fourth terminal -   292 fifth terminal element -   292A fifth terminal -   302 memory -   304 database -   306 connection -   308 transmitter -   310 signal -   312 bus -   314 processor -   316 memory -   318 operating state module -   320 sensor data module -   322 previous wear time module -   324 actual wear time module -   326 monitor interface -   328 receiver -   330 sensor -   331 remote sensor -   332 input device -   334 display -   336 operating state -   338 sensor data parameters -   338A sensor data parameter X₁ -   338A1 example sensor parameter value of sensor data parameter X₁ -   338A2 example sensor parameter value of sensor data parameter X₁ -   338A3 example sensor parameter value of sensor data parameter X₁ -   338B sensor data parameter X₂ -   338B1 example sensor parameter value of sensor data parameter X₂ -   338B2 example sensor parameter value of sensor data parameter X₂ -   338B3 example sensor parameter value of sensor data parameter X₂ -   338C sensor data parameter X_(n) -   338C1 example sensor parameter value of sensor data parameter X_(n) -   338C2 example sensor parameter value of sensor data parameter X_(n) -   338C3 example sensor parameter value of sensor data parameter X_(n) -   344 actual wear time -   344A1 example of wear time value -   344B1 example of wear time value -   344C1 example of wear time value -   344D example of actual wear time -   344E example of actual wear time -   346 wear time lookup table -   354 previous wear time lookup table -   356 previous sensor parameters values -   356A example previous sensor parameter value -   356B example previous sensor parameter value -   356C example previous sensor parameter value -   356D example previous sensor parameter value -   356E example previous sensor parameter value -   356F example previous sensor parameter value -   356G example previous sensor parameter value -   356H example previous sensor parameter value -   356I example previous sensor parameter value -   357A example sensor parameter value -   357B example sensor parameter value -   357C example sensor parameter value -   357D example sensor parameter value -   357E example sensor parameter value -   357F example sensor parameter value -   358 previous wear times -   358A example of previous wear time -   358B example of previous wear time -   358C example of previous wear time -   358D example of previous wear time -   358E example of previous wear time -   360 graph -   362 time point -   364 activity input data -   366 activity -   366A activity A -   366B activity B -   366N activity C -   368 graph -   370 best-fit line -   1000 curve representing the upper voltage threshold value -   1002 curve representing the medium voltage threshold value -   1004 curve representing the lower voltage threshold value -   1006 curve representing a gradient limit -   1100 curve showing, as a function of time, first parameter data     indicative of voltage measured by the first electrode pair of the     base plate -   1102 curve showing, as a function of time, second parameter data     indicative of voltage measured by the second electrode pair of the     base plate -   1104 curve showing, as a function of time, third parameter data     indicative of voltage measured by the third electrode pair of the     base plate -   1108 curve showing, as a function of time, fourth primary parameter     indicative of voltage measured by the fourth electrode pair of the     base plate -   1110 curve showing, as a function of time, a gradient of fourth     primary parameter indicative of voltage gradient -   1112 curve showing, as a function of time, a gradient of fourth     secondary parameter indicative of voltage gradient measured -   1114 curve showing, as a function of time, a gradient of fourth     tertiary parameter indicative of voltage gradient measured -   1116 curve showing, as a function of time, a fourth secondary     parameter indicative of voltage measured -   1118 curve showing, as a function of time, a fourth tertiary     parameter indicative of voltage measured -   1200 curve showing, as a function of time, third parameter data     indicative of voltage measured by the third electrode pair of the     base plate -   1202 curve showing, as a function of time, first parameter data     indicative of voltage measured by the first electrode pair of the     base plate -   1204 curve showing, as a function of time, second parameter data     indicative of voltage measured by the second electrode pair of the     base plate -   1206 curve showing, as a function of time, a fourth primary     parameter indicative of voltage measured by the fourth electrode     pair of the base plate -   1208 curve showing, as a function of time, a fourth secondary     parameter indicative of voltage measured -   1210 curve showing, as a function of time, a fourth tertiary     parameter indicative of voltage measured -   1212 curve showing, as a function of time, a gradient of fourth     primary parameter indicative of voltage gradient measured by the     fourth electrode pair of the base plate -   1214 curve showing, as a function of time, a gradient of fourth     secondary parameter data indicative of voltage gradient measured -   1216 curve showing, as a function of time, a gradient of fourth     tertiary parameter indicative of voltage gradient measured -   1300 curve showing, as a function of time, first parameter data     indicative of voltage measured by the first electrode pair of the     base plate -   1302 curve showing, as a function of time, second parameter data     indicative of voltage measured by the second electrode pair of the     base plate -   1304 curve showing, as a function of time, third parameter data     indicative of voltage measured by the third electrode pair of the     base plate -   1306 curve showing, as a function of time, a fourth primary     parameter indicative of voltage measured by the fourth electrode     pair of the base plate -   1308 curve showing, as a function of time, a fourth secondary     parameter indicative of voltage measured -   1310 curve showing, as a function of time, a fourth tertiary     parameter indicative of voltage measured -   1312 curve showing, as a function of time, a gradient of fourth     primary parameter indicative of voltage gradient measured by the     fourth electrode pair of the base plate -   1314 curve showing, as a function of time, a gradient of fourth     secondary parameter indicative of voltage gradient measured -   1316 curve showing, as a function of time, a gradient of fourth     tertiary parameter indicative of voltage gradient measured -   1502 curve showing, as a function of time, first parameter data     indicative of voltage measured by the first electrode pair of the     base plate -   1504 curve showing, as a function of time, second parameter data     indicative of voltage measured by the second electrode pair of the     base plate -   1506 curve showing a diameter of the white ring as a function of     time -   1602 curve showing peel force applied to the first adhesive layer in     a dry adhesive state as a function of peeling distance -   1604 a peel force applied to the first adhesive layer as a function     of a peeling distance traveled by a peeling action exercising the     peel force on the first adhesive layer in a wet adhesive state -   1606 a peel force applied to the first adhesive layer as a function     of a peeling distance traveled by a peeling action exercising the     peel force on the first adhesive layer partially wet -   1608 length of the first adhesive layer 1608 in dry adhesive state -   1610 the first adhesive layer which comprises a first portion in a     dry adhesive state and a second portion in a wet adhesive state -   1610A a first portion in a dry adhesive state -   1610B a second portion in a wet adhesive state -   2104 curve showing a function of time, a diameter of the white ring     of a base plate of the first type measured from a cut for a stomal     opening to the first electrode pair -   2102 a linear approximation of curve 2104 -   2106 curve showing, as function of time, a diameter of the white     ring of a base plate of the first type measured from the first     electrode pair to the second electrode pair -   2108 a linear approximation of curve 2106 -   2110 a linear approximation of curve 2112 -   2112 curve showing, as function of time, a diameter of the white     ring of a base plate of the second type measured from a cut for a     stomal opening to the first electrode pair -   2114 curve showing, as a function of time, a diameter of the white     ring of a base plate of the second type measured from the first     electrode pair to the second electrode pair -   2116 a linear approximation of curve 2114 -   2202 curve showing, as a function of time, first parameter data -   2204 curve showing, as a function of time, first parameter data -   2204A curve showing, as a function of time, first parameter data     indicative of voltage measured by the first electrode pair of the     base plate when a mixture of 30% output and 70% tap water is applied -   2206 curve showing, as a function of time, first parameter data     indicative of voltage measured by the first electrode pair of the     base plate when a mixture of 30% output and 70% tap water is applied -   2208 curve showing, as a function of time, first parameter data     indicative of voltage measured by the first electrode pair of the     base plate when a mixture of 50% output and 50% tap water is applied -   2210 curve showing, as a function of time, first parameter data     indicative of voltage measured by the first electrode pair of the     base plate when a mixture of 100% output and 0% tap water is applied -   2212 curve showing, as a function of time, first parameter data     indicative of voltage measured by the first electrode pair of the     base plate when a mixture of 100% output and 0% tap water is applied -   2214 curve showing a linear approximation relating the trigger times     of the first electrode pair to the percentage of output -   2302 a graphical representation of parameter data as a function of     time at a first predetermined temperature -   2304 a graphical representation of parameter data as a function of     time at a second predetermined temperature -   2306 curve showing, as a function of time, a decrease in voltage for     the first electrode pair at a first predetermined temperature -   2308 curve showing, as a function of time, a constant voltage for     the second electrode pair at the first predetermined temperature -   2310 curve showing, as a function of time, a constant voltage for     the third electrode pair at the first predetermined temperature -   2312 curve showing, as a function of time, a decrease in voltage for     the first electrode pair at a second predetermined temperature -   2314 curve showing, as a function of time, a constant voltage for     the second electrode pair at the second predetermined temperature -   2316 curve showing, as a function of time, a constant voltage for     the third electrode pair at the second predetermined temperature -   M number of terminals in the first interface of the monitor device 

1. An accessory device for a medical system comprising a monitor device and a medical appliance, the medical appliance comprising a base plate, the accessory device comprising: a memory; a processor; and a monitor interface coupled to the processor and configured to communicate with the monitor device and to obtain monitor data from the monitor device coupled to the medical appliance, wherein the processor is configured to: determine an operating state of the base plate; receive a sensor parameter value corresponding to a sensor data parameter from at least one sensor; determine an actual wear time of the medical appliance based on the operating state and the sensor parameter value.
 2. The accessory device according to claim 1, wherein to determine the actual wear time, the processor is configured to determine a previous wear time.
 3. The accessory device according to claim 2, wherein to determine the actual wear time, the processor is configured to determine an adjustment to the previous wear time based on the sensor parameter value.
 4. The accessory device according to claim 1, wherein to determine the actual wear time, the processor is configured to: obtain a previous sensor parameter value for the sensor data parameter; compare the previous sensor parameter value to the sensor parameter value; and determine the actual wear time based on the comparison.
 5. The accessory device according to claim 1, wherein the sensor parameter value is at least one of: a current sensor parameter value and a future sensor parameter value.
 6. The accessory device according to claim 1, wherein the at least one sensor is included in the accessory device.
 7. The accessory device according to claim 1, wherein the at least one sensor comprises a plurality of sensors and at least one sensor of the plurality of sensors is a remote sensor.
 8. The accessory device according to claim 1, wherein the sensor data parameter comprises at least one of: temperature data, humidity data, activity data, stoma data, accelerometer data, image data, sound data, input data, and heart-rate data.
 9. The accessory device according to claim 1, wherein the at least one sensor comprises at least one of: an audio sensor, an accelerometer, a gyroscope, a magnetometer, a barometer, a camera, a proximity sensor, a temperature sensor, a heart-rate sensor, and a fingerprint sensor.
 10. The accessory device according to claim 1, wherein to determine the operating state, the processor is configured to receive the operating state.
 11. A method of operating an accessory device for a medical system comprising a monitor device and a medical appliance, the medical appliance comprising a base plate, the method comprising: determining an operating state of the base plate; receiving a sensor parameter value corresponding to a sensor data parameter from at least one sensor; and determining an actual wear time of the medical appliance based on the operating state and the sensor parameter value.
 12. The method according to claim 11, wherein determining the actual wear time comprises obtaining a previous wear time.
 13. The method according to claim 12, wherein determining the actual wear time comprises determining an adjustment to the previous wear time based on the sensor parameter value.
 14. The method according to claim 11, wherein determining the actual wear time comprises: obtaining a previous sensor parameter value for the sensor data parameter; comparing the previous sensor parameter value to the sensor parameter value; and determining the actual wear time based on the comparison.
 15. The method according to claim 11, wherein the sensor parameter value is at least one of: a current sensor parameter value and a future sensor parameter value. 